3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT 12 HOLES 157 MM LENGTH · SCREW, FIXATION, BONE/TRAUMA
ZIMMER BIOMET, INC. · Fracture
- Report to FDA
- N
- Manufacturer contact t name
- MS.
- Manufacturer contact state
- IN
- Manufacturer link flag
- Y
- Manufacturer g1 city
- WARSAW
- Manufacturer contact address 1
- 56 E. BELL DR.
- Manufacturer contact pcity
- 57452603
- Event type
- Injury
- Report number
- 0001822565-2023-02171
- Product problem flag
- Y
- Date received
- 20230815
- PMA pmn number
- K060710
- Date of event
- 20211215
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 46582
- Reporter occupation code
- 003
- Manufacturer contact plocal
- 5745260384
- Noe summarized
- 1
- Manufacturer contact l name
- RAPSAVAGE
- Manufacturer g1 postal code
- 46580
- Manufacturer g1 state
- IN
- Reporter country code
- CH
- Manufacturer contact area code
- 574
- Date added
- 20230815
- Manufacturer contact f name
- JENNIFER
- Device date of manufacturer
- 20180731
- Previous use code
- I
- Suppl dates mfr received
- 09/22/2023
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20250819
- Summary report flag
- N
- Manufacturer contact phone number
- 5745
- Date report
- 20230922
- Initial report to FDA
- No
- Manufacturer g1 country
- US
- Manufacturer contact city
- WARSAW
- MDR report key
- 17550513
- Date manufacturer received
- 20230721
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 46580
- Manufacturer g1 name
- ZIMMER BIOMET, INC.
- Adverse event flag
- Y
- Single use flag
- Y
- Manufacturer g1 address 1
- 1800 W. CENTER ST.
- Manufacturer contact postal code
- 46582
- Manufacturer contact exchange
- 574
- Suppl dates FDA received
- 09/25/2023
- Type of report
- Initial submission, Followup
- Source type
- Foreign, Health Professional, Company representation
- Device
- Device sequence number
- 962768
- Implant date year
- 2019
- Date removed year
- 2021
- Serviced by 3rd party flag
- U
- Date received
- 20230815
- Brand name
- 3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT 12 HOLES 157 MM LENGTH
- Generic name
- SCREW, FIXATION, BONE/TRAUMA
- Manufacturer d name
- ZIMMER BIOMET, INC.
- Manufacturer d address 1
- 1800 W. CENTER ST.
- Manufacturer d city
- WARSAW
- Manufacturer d state
- IN
- Manufacturer d zip code
- 46580
- Manufacturer d country
- US
- Manufacturer d postal code
- 46580
- Device operator
- HEALTH PROFESSIONAL
- Catalog number
- 47493601213
- Lot number
- 64102138
- Device availability
- No
- Device report product code
- HWC
- Device age text
- DA
- Device evaluated by manufacturer
- R
- Combination product flag
- N
- UDI di
- 00889024104266
- UDI public
- (01)00889024104266(17)280731(17)64102138
- Harmonized identifiers (openFDA)
- Device name
- Screw, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3040
- Device class
- 2
- Product problems
- Fracture, Fracture
- Patient
- Patient sequence number
- 1
- Date received
- 20230815
- Patient age
- 48 YR
- Patient sex
- Female
- Sequence number outcome
- Required Intervention, H
- Patient problems
- Failure of Implant, Pain, Failure of Implant, Pain
- MDR text
- MDR text key
- 337425997
- Text type code
- Description of Event or Problem
- Patient sequence number
- 0
- Text
- NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
- MDR text key
- 337425998
- Text type code
- Additional Manufacturer Narrative
- Patient sequence number
- 0
- Text
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED TWO PIECES OF THE FRACTURED PLATE, AS WELL AS 4 SCREWS USED IN FIXATION. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE PRODUCT HOLD ASSOCIATED WITH THIS LOT IS FOR AN INCORRECT TAPER ANGLE ON THE SCREW THREAD FORMS. THE FRACTURED PLATE IN THIS COMPLAINT BROKE BETWEEN TWO SCREW HOLES, SO THE THREAD TAPER ANGLE WOULD NOT BE RELATED TO THE REPORTED EVENT. ADDITIONALLY, THE SCREW HOLE NEAR THE FRACTURE DID NOT HAVE A SCREW IN IT WHEN THE DEVICE FRACTURED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INTERVAL PLACEMENT OF A PLATE AND SCREW FIXATION DEVICE AND BONE GRAFT MATERIAL INVOLVING THE PROXIMAL ULNAR DIAPHYSIS WITH THE METAL FRACTURE OF THE PLATE AND REVISION. OVERALL FIT AND ALIGNMENT OF THE ORIGINAL ULNAR PLATE IS APPROPRIATE. BONE GRAFT MATERIAL IS SEEN. NO SIGNS OF LOOSENING. FRACTURED ULNAR PLATE NOTED. INCOMPLETE HEALING OF THE BONE GRAFT IS. SUSPECTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
- MDR text key
- 321224367
- Text type code
- Additional Manufacturer Narrative
- Patient sequence number
- 0
- Text
(B)(4). D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN LOCKING SCREW; LOT#: UNKNOWN; QUANTITY: 11. G2: FOREIGN: CHINA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED BY THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
- MDR text key
- 321224368
- Text type code
- Description of Event or Problem
- Patient sequence number
- 0
- Text
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT ULNA ORIF SURGERY FOUR YEARS AGO. SUBSEQUENTLY, THE PATIENT APPROXIMATELY A YEAR AND A HALF AGO REPORTED SUDDEN PAIN IN THEIR RIGHT ARM AND THE IMPLANT HAD FRACTURED IN LEFT RIGHT FOREARM. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY TWO WEEKS LATER AND THE FRACTURED IMPLANT WAS EXPLANTED AND A NEW IMPLANT WAS IMPLANTED INTO THE PATIENT'S RIGHT ARM.