HANDPIECE, ELECTRIC DERMATOME
Report
- Report Number
- 0001526350-2025-00446
- Event Type
- Malfunction
- Date Received
- April 7, 2025
- Date of Event
- March 10, 2025
- Report Date
- August 26, 2025
- Manufacturer
- ZIMMER SURGICAL, INC.
- Product Code
- GFD
- UDI-DI
- 00889024375994
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). FOLLOWING SECTIONS WERE UPDATED OR CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H6, AND H11. 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.
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). FOLLOWING SECTIONS WERE UPDATED OR CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H6, AND H11. 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.
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). FOLLOWING SECTIONS WERE UPDATED OR CORRECTED: B4, B5, D2, D4, G1, G3, G6, H1, H2, H3, H4, H6, AND H11. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THAT THE DEVICE WOULD NOT POWER ON. THE CONTROL BAR WAS LOOSE. THE HEAD PIECE WAS DAMAGED. THE ECCENTRIC SHAFT ASSEMBLY, SWITCH MOUNT, POWER SWITCH AND MACHINED HEAD WERE REPLACED AND UNIT WAS RECALIBRATED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE 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.
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.
IT WAS REPORTED THAT DURING SURGERY, THE MOTOR FROZE UP. THE UNIT WAS NOT CUTTING PROPERLY, AND SOMETIMES IT WOULD TURN ON, OTHER TIMES IT WOULD NOT. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY REPORTED. DUE DILIGENCE IS IN PROCESS; NO FURTHER INFORMATION IS AVAILABLE.THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
IT WAS REPORTED THAT DURING SURGERY, THE MOTOR FROZE UP. THE UNIT WAS NOT CUTTING PROPERLY. THE UNIT DOES NOT STAY ON, AND SOMETIMES IT WOULD TURN ON, OTHER TIMES IT WOULD NOT. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY REPORTED. DUE DILIGENCE IS IN PROCESS; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
IT WAS REPORTED THAT DURING SURGERY, THE MOTOR FROZE UP. THE UNIT WAS NOT CUTTING PROPERLY. THE UNIT DOES NOT STAY ON, AND SOMETIMES IT WOULD TURN ON, OTHER TIMES IT WOULD NOT. IT WAS ONLY ONE EVENT DATE. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY REPORTED. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
IT WAS REPORTED THAT DURING SURGERY, THE MOTOR FROZE UP. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY REPORTED. DUE DILIGENCE IS IN PROCESS, NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1570055 | HANDPIECE, ELECTRIC DERMATOME | DERMATOME | GFD | ZIMMER SURGICAL, INC. | 65154602 | 00889024375994 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |