InjuryHTJ
SYNTHES DEPTH GAUGE
Received May 9, 2022 · Event occurred May 3, 2022
Report MW5109602 · MDR key 14345624
Device
Generic name
Gauge, Depth
Manufacturer
Depuy Synthes Companies / Depuy Intl., Ltd.Product problems
- Break
Patient
67 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
PHYSICIAN USED THE SYNTHES DEPTH GAUGE PROPERLY. HE HOOKED THE FAR CORTEX OF THE BONE TO ASSESS THE SCREW LENGTH, AND IN THE PROCESS, THE TIP OF THE DEPTH GAUGE BROKE OFF. THE FRAGMENT GENERATED REMAINED IN THE PATIENT, AS SHOWN BY INTRA-OPERATIVE IMAGING. PHYSICIAN THEN RETRIEVED THE FRAGMENT. NO FRAGMENTS REMAINED IN PATIENT AS SHOWN BY INTRA-OPERATIVE IMAGING. THE CASE WAS COMPLETED SUCCESSFULLY WITH AN ESTIMATED TIME DELAY OF 60 MINUTES PER PHYSICIAN. FDA SAFETY REPORT ID# (B)(4).