TRIMMING SCISSORS
Received Jul 15, 2022 · Event occurred Jun 28, 2022
Report 1818910-2022-13062 · MDR key 15026614
Device
Product problems
- Failure to Cut
- Material Deformation
- Failure to Cut
- Material Deformation
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE ITEM IS DAMAGED AND IN NEED OF REPLACING. THE PLASTIC PART HAS MELTED AND THE SHARPNESS OF THE BLADE HAS BEEN AFFECTED. THERE WAS A FEW MINUTES ADDED TO THEATRE TIME SO THEY COULD OPEN ANOTHER TRAY.
Additional Manufacturer Narrative
PRODUCT COMPLAINT (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED FOR EXAMINATION. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS, THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED. AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE) WAS NOT POSSIBLE, BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.