GLENOSPHERE FORCEPS
Received May 31, 2019
Report 0001825034-2019-02400 · MDR key 8658116
Device
Generic name
Chisel, Surgical
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
406236
Lot number
NI
Product problems
- Fracture
- Fracture
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE COMPLAINT CANNOT BE CONFIRMED BASED ON THE LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02177.
Description of Event or Problem
IT HAS BEEN REPORTED THAT DURING SURGERY, THE GLENOSPHERE INSERTER FRACTURED AND THE FRACTURED PIECE RETAINED INSIDE PATIENT'S BODY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.