BONE DEPTH GAUGE
Received Apr 1, 2026 · Event occurred Oct 3, 2025
Report 0001825034-2026-00810 · MDR key 24757465
Device
Generic name
Gauge, Depth
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
231200100
Lot number
NI
Product problems
- Device Markings/Labelling Problem
- Naturally Worn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. G2: FOREIGN, EVENT OCCURRED IN (B)(6). THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED; LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. 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.
Description of Event or Problem
IT WAS REPORTED THAT A CONSIGNED METER FAILED TO FULFILL ITS FUNCTION, WITH METER READINGS ERASED, AND A REPLACEMENT WAS REQUESTED. THERE WAS NO REPORTED PATIENT IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.