ME1000 CUP-ADAPTER-PINNACLE STRAIGHT
Received Jan 22, 2019 · Event occurred Jan 9, 2019
Report 1045834-2019-52682 · MDR key 8266872
Device
Generic name
Impactor, Adapters, Battery, Battery Charger
Manufacturer
Depuy Synthes Products LlcCatalog number
1011-01-101
Lot number
N/A
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE ADAPTER DEVICE WAS EVALUATED AND THE REPORTED CONDITION THAT THE CLOVER LEAF FITTING GUIDE WAS DETACHED FROM THE ADAPTER AND THE THREADED PORTION WAS BROKEN OFF INSIDE WHERE IT ATTACHES WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED AND IT WAS OBSERVED THAT THE UNIT HAD A BROKEN T-HANDLE, AND THE PINNACLE ADAPTER WAS NON-FUNCTIONAL. IT WAS DETERMINED THAT THE UNIT MOST LIKELY WAS USED SLIDE LOAD WITH THE IMPACTOR, WHICH IS NOT WHAT THE UNIT WAS DESIGNED FOR. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE COMPONENT DAMAGE DUE TO USER MISUSE. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE DETECTED RELATED TO THE REPORTED CONDITION. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative
THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE EVALUATION OF THE DEVICE HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRETEST, IT WAS OBSERVED THAT THE CLOVER LEAF FITTING GUIDE WAS DETACHED FROM THE ADAPTER DEVICE AND THE THREADED PORTION WAS BROKEN OFF INSIDE WHERE IT ATTACHES. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRE-TEST FOR VISUAL ASSESSMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.