ARCOS 3.5MM HEX DRIVE
Received Nov 11, 2020 · Event occurred Oct 20, 2020
Report 0001825034-2020-04081 · MDR key 10823959
Device
Generic name
Instrument, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
31-301852
Lot number
568849
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: UPON VISUAL INSPECTION THE DEVICE HAD FRACTURED AT THE TIP. THERE IS VISIBLE WEAR TO THE DEVICE ON THE SHAFT AND HANDLE. FURTHER ANALYSIS REVEALED THAT THE FRACTURE SURFACE ARTIFACTS INDICATE THE BENDING OVERLOAD FAILURE MODE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
(B)(4). PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A HEX DRIVER BROKE WHILE USING IN A DEMONSTRATION. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.