ENTRY REAMER FLEXIBLE SHAFT
Received Jun 30, 2026 · Event occurred Dec 12, 2025
Report 0001822565-2026-02356 · MDR key 25665904
Device
Product problems
- Material Deformation
Patient
66 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - DRILL. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF USE AS WELL AS WEAR AND TEAR. THE CONNECTING FEATURE OF THE DEVICE HAS SCRATCHES AND KNICKS FROM USE. THE FLEXIBLE SHAFT OF THE REAMER HAS CRACKED ON THE LAST LINK THAT IS CLOSEST TO THE REAMER HEAD AS SHOWN IN THE PHOTOS. THE REAMER HEAD HAS KNICKS AND WEAR ON THE EDGES. THE DEVICE HAS A POSSIBLE FIELD AGE OF 11+ YEARS WITH A MANUFACTURING DATE OF JUN 10, 2014. MEASURED FEATURES OF THE DEVICE TO CONFIRM IT IS CONFORMING TO PRINT SPECIFICATIONS MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.
Description of Event or Problem
IT WAS REPORTED THAT A REAMER HAD A REPORTED ISSUE. INVESTIGATION RESULTS EVALUATED THE REAMER TO BE FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.