LEXER CHISEL, 12/200 MM
Report
- Report Number
- 0009613350-2021-00652
- Event Type
- Malfunction
- Date Received
- December 7, 2021
- Date of Event
- November 10, 2021
- Report Date
- March 8, 2022
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- FZO
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. INVESTIGATION AND CONCLUSION: 1. EVENT DESCRIPTION: ON THE 10.11.2021, INSTRUMENTS COORDINATOR WAS PICKING FOR THE NEXT DAY BOOKING, HE OPENED ALL THE INSTRUMENTS TRAYS, AT THAT POINT WE WHERE DOING AUDIT, I DID A SPOT CHECK ON THE INSTRUMENTS, WHERE TO FIND OUT ITEM OR INSTRUMENT 75.12.91 LEXER CHISEL, WAS BLUNT AND THE TIP WAS HAVING BROKEN CHIPS. I HAVE INVESTIGATED AND REVERT TO THE LAST USER, HE DECLARED HE DIDN¿T USE THE CHISEL. NO PATIENT INVOLVEMENT. HARM: S1 - NO PATIENT, USER, OR OTHER STAKEHOLDER HARM. HAZARDOUS SITUATION: DEVICE NOT USED FOR IMPLANTATION DUE TO NON-FUNCTIONALITY OR VISIBLE DAMAGES. 2. REVIEW OF RECEIVED DATA: NO MEDICAL DATA RELEVANT TO THE CASE HAS BEEN RECEIVED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. 3. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 4. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE DHR DOCUMENTS WERE CHECKED AND IT CAN BE SEEN THAT A PROTECTION ELEMENT WAS USED FOR THIS DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ON (B)(6) 2017, AN INCOMING INSPECTION WAS DONE. THERE WAS NO ISSUE NOTED, ALL TESTED PARTS WERE ACCORDING TO SPECIFICATION. . 5. CONCLUSION: ON THE 10.11.2021, INSTRUMENTS COORDINATOR WAS PICKING FOR THE NEXT DAY BOOKING, HE OPENED ALL THE INSTRUMENTS TRAYS, AT THAT POINT WE WHERE DOING AUDIT, I DID A SPOT CHECK ON THE INSTRUMENTS, WHERE TO FIND OUT ITEM OR INSTRUMENT 75.12.91 LEXER CHISEL, WAS BLUNT AND THE TIP WAS HAVING BROKEN CHIPS. I HAVE INVESTIGATED AND REVERT TO THE LAST USER, HE DECLARED HE DIDN¿T USE THE CHISEL. NO PATIENT INVOLVEMENT. NO PRODUCT WAS RETURNED, HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PART(S) IS UNKNOWN. NO PICTURE OF THE DEVICE HAS BEEN RECEIVED. BASED ON THE INVESTIGATION THE REPORTED EVENT CANNOT BE CONFIRMED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. NEW INFORMATION RECEIVED: - THE EVENT HAPPENED ON (B)(6) 2021. - CORRECT LOT NUMBER IS: 4501785460. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2021-00652.
THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). PRODUCT NOT AVAILABLE.
INVESTIGATION RESULTS ARE NOW AVAILABLE.
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. WAS BLUNT AND THE TIP WAS HAVING BROKEN CHIPS. ADDITIONAL INFORMATION WAS RECEIVED: THE EVENT HAPPENED ON (B)(6) 2021. THE CORRECT LOT NUMBER IS: 4501785460.
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. WAS BLUNT AND THE TIP WAS HAVING BROKEN CHIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1843977 | LEXER CHISEL, 12/200 MM | HIP INSTRUMENT | FZO | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 4501785460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |