A&E MEDICAL / ROTATING SURGICAL PUNCHES
Received Apr 25, 2023 · Event occurred Mar 28, 2023
Report 0001032347-2023-00143 · MDR key 16811333
Device
Generic name
Punch, Surgical
Manufacturer
Biomet MicrofixationModel number
N/ACatalog number
080-481
Lot number
08539
Product problems
- Failure to Cut
- Failure to Cut
Patient
NA · Unknown
- Perforation of Vessels
- Perforation of Vessels
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PUNCH. THE PUNCH WAS RETURNED WITH ORIGINAL PACKAGING, THE PACKAGING WAS OPENED AND THE PUNCH SHOWS LIGHT SIGNS OF USE. WHEN THE PLUNGER WAS PULLED BACK ON THE PUNCH THE CUTTING TIP FULL RETRACTED INTO THE PUNCH BODY AS DESIGNED. THERE WERE NO SIGNS OF BINDING OR MANUFACTURING DEFECTS. WHEN THE PLUNGER WAS RELEASED THE PUNCH RETURNED TO ITS ORIGINAL POSITION AS DESIGNED. THE COMPLAINT CANNOT BE RECREATED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT WAS REPORTED UNDER THE INCORRECT MFR NUMBER. THE EVENT WILL BE REPORTED UNDER THE CORRECT MFR NUMBER 0002242056-2024-00007; THEREFORE, THIS REPORT SHOULD BE VOIDED.
Description of Event or Problem
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT WAS REPORTED UNDER THE INCORRECT MFR NUMBER AND SHOULD THEREFORE BE VOIDED.
Additional Manufacturer Narrative
ZIMMER BIOMET COMPLAINT (B)(4). D2: PRODUCT CODE: LRY. 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.
Description of Event or Problem
IT WAS REPORTED BY THE REP THAT THE PUNCH DID NOT MAKE A CLEAN CUT AND THE SURGEON HAD TO DO ADDITIONAL SUTURING TO THE SITE. DELAY IS THOUGHT TO BE 2 TO 3 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.