5.0MM TI W/ MAXBRAID NDLS
Report
- Report Number
- 0001825034-2022-00287
- Event Type
- Injury
- Date Received
- February 9, 2022
- Date of Event
- January 27, 2022
- Report Date
- April 15, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HWC
- UDI-DI
- 00880304009677
- PMA / PMN Number
- K080088
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT PRODUCTS: CAT: 902571 LOT: 173540 5.0MM TI W/ MAXBRAID NDLS. CAT: 902581 LOT: 362840 5.0 ALLTHREAD TI 2#2 MB TPRD N. CAT: 902582 LOT: 451440 6.5 ALLTHREAD TI 2#2 MB TPRD N. REPORT SOURCE: FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. PRODUCT REMAINS IMPLANTED.
(B)(4). CONCOMITANT PRODUCTS: CAT: 902571 LOT: 173540 5.0MM TI W/ MAXBRAID NDLS. CAT: 902581 LOT: 362840 5.0 ALLTHREAD TI 2#2 MB TPRD N. CAT: 902582 LOT: 451440 6.5 ALLTHREAD TI 2#2 MB TPRD N. REPORT SOURCE: FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. PRODUCT REMAINS IMPLANTED.
REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.
IT WAS REPORTED THAT DURING THE PROCEDURE, THE TISCREW ANCHORS BROKE AND WERE RETAINED IN THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT DURING THE PROCEDURE, THE TISCREW ANCHORS BROKE AND WERE RETAINED IN THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1086190 | 5.0MM TI W/ MAXBRAID NDLS | SCREW, FIXATION | HWC | ZIMMER BIOMET, INC. | 902571 | 070670 | 00880304009677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other| R | SEE NARRATIVE IN H10 |