NCB-DF PLATE RIGHT, 13 HOLES, L. 324 MM
Report
- Report Number
- 0009613350-2022-00320
- Event Type
- Injury
- Date Received
- June 2, 2022
- Date of Event
- May 14, 2022
- Report Date
- April 3, 2023
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- NDF
- UDI-DI
- 00889024297388
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE SIZING OF THE IMPLANT IS APPROPRIATE. HOWEVER, THE LATERAL PLATE AND SCREW FIXATION DEVICE IS FRACTURED ON THE POST REVISION IMAGES. POSSIBLE LOOSENING OF THE DISTAL INTERLOCKING SCREWS WAS ALSO SEEN ON THIS IMAGE. NO CONTRIBUTING FACTORS ARE SEEN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PRODUCT HAS NOW BEEN RETURNED. VISUAL EXAMINATION OF THE RETURNED PRODUCT PICTURES IDENTIFIED: THE COMPLAINED NCB PLATE AS WELL AS THE ASSOCIATED NCB SCREWS AND LOCKING CAPS WERE RETURNED FOR EXAMINATION. THE REPORTED EVENT OF PLATE FRACTURE CAN BE CONFIRMED. THE PLATE HAS BROKEN INTO TWO FRAGMENTS. THE FRACTURE OF THE PLATE IS LOCATED THROUGH A SCREW HOLE. ON THE FRACTURE SURFACES OF THE PLATE, SOME BEACH MARKS ARE VISIBLE WHICH POINT TO A FATIGUE FRACTURE. THE FRACTURE ORIGINS ARE LOCATED AT THE BEGINNING OF THE CHAMFER ON THE NON-BONE-FACING SIDE. ON THE FRACTURE SURFACES THERE ARE ALSO POLISHED AREAS AND SOME SCRATCHES, MOST PROBABLY DUE TO CONTACT BETWEEN THE PARTS AFTER THE FRACTURE. SEVERAL SCRATCHES ARE VISIBLE ON THE SURFACE OF THE PLATE. THE NCB SCREWS AS WELL AS THE LOCKING CAPS APPEAR MAINLY INCONSPICUOUS. NO CHANGE TO THE CONCLUSION OF THE ORIGINAL INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE TRAUMA PLATE BROKE APPROXIMATELY 4 MONTHS AFTER IMPLANTATION AND REVISION SURGERY WAS PERFORMED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159022 | NCB-DF PLATE RIGHT, 13 HOLES, L. 324 MM | TRAUMA IMPLANT | NDF | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3050589 | 00889024297388 |
| 2828760 | NCB-DF PLATE RIGHT, 13 HOLES, L. 324 MM | TRAUMA IMPLANT | NDF | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3050589 | 00889024297388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Required Intervention| H |