DEPTH GAUGE
Received Nov 17, 2016 · Event occurred Oct 24, 2016
Report 0001032347-2016-00679 · MDR key 6110069
Device
Generic name
Depth Gauge
Manufacturer
Biomet MicrofixationModel number
N/ACatalog number
SP-1248
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE PRODUCT CODE: EIL. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT WAS REQUESTED BUT WILL NOT BE RETURNED FOR AN EVALUATION. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem
IT WAS REPORTED THAT A DEPTH GAUGE BROKE INTO TWO PIECES DURING A PROCEDURE. IT IS REPORTED THAT THE BREAKAGE WAS DUE TO BEING WORN OUT AND OVER USED. IT IS REPORTED THE TWO PIECES DID NOT FALL INTO THE PATIENT. IT IS REPORTED THAT NO DELAY OVER THIRTY MINUTES OCCURRED AS A RESULT OF THIS EVENT. IT IS REPORTED THE PROCEDURE WAS COMPLETED WITH A SPARE DEPTH GAUGE.