DERMATOME BLADES
Report
- Report Number
- 0001526350-2023-01307
- Event Type
- Injury
- Date Received
- October 10, 2023
- Date of Event
- August 24, 2023
- Report Date
- January 12, 2024
- Manufacturer
- ZIMMER SURGICAL, INC.
- Product Code
- GFD
- UDI-DI
- 00889024375895
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- ZFA 2023-00208
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 001526350-2023-01306-01.
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER CMP-(B)(4). FOLLOWING SECTIONS WERE UPDATED OR CORRECTED: B4, B5, D2, D4, G1, G3, G6, H1, H2, H3, H4, H6, AND H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A DESIGN AND MANUFACTURING ISSUE. THE EVENT IS CONFIRMED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-01306-3.
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 001526350-2023-01306-2.
AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 001526350-2023-01306.
IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT TAKE A CLEAN PIECE OF SKIN AND THE TAKEN GRAFT WAS DAMAGED. THE TEAM SWITCHED OUT THE BLADES WITH A NEW ONE WHICH TOOK A SUCCESSFUL ADDITIONAL GRAFT. THERE WERE NO ISSUES OR COMPLAINTS AFTER THE NEW BLADE WAS USED. THERE WAS NO DELAY NOTED. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.
THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE DEVICE DID NOT TAKE A CLEAN PIECE OF SKIN. THE TEAM SWITCHED OUT THE BLADES WITH A NEW ONE. THERE WERE NO ISSUES OR COMPLAINTS AFTER THE NEW BLADE WAS USED. THERE WAS NO HARM OR DELAY NOTED. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296172 | DERMATOME BLADES | DERMATOME BLADE, SINGLE-USE | GFD | ZIMMER SURGICAL, INC. | N/A | 65972712 | 00889024375895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Male | Required Intervention| O |