DEPTH GAGE 2.0/2.4 45MM LONG
Received Feb 14, 2022
Report 0001032347-2022-00048 · MDR key 13522708
Device
Generic name
Gauge, Depth, Instrument, Dental
Manufacturer
Biomet MicrofixationModel number
N/ACatalog number
01-9125
Lot number
UNK
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ZIMMER BIOMET COMPLAINT (B)(4). DEVICE PRODUCT CODE: EIL. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE IS BROKEN. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAYS INVOLVED.
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS LOST POST RECEIPT. AS A RESULT FUNCTIONAL AND VISUAL TESTING CANNOT BE COMPLETED ON THESE ITEMS. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED FOR THE DEPTH GAUGE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.