UNKNOWN BURR TIP
Received Jan 27, 2018 · Event occurred May 15, 2015
Report 0001825034-2018-00417 · MDR key 7223802
Device
Generic name
Instrument, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
NI
Lot number
NI
Product problems
- Fracture
- Fracture
Patient
52 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE BURR TIP WAS BROKEN. THIS CONTRIBUTED TO AN HOUR AND A HALF DELAY TO SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED.