BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED II UNIVERSAL GLENOID BASEPLATE IMPACTOR

    MDR report key: 12004247 · Received June 15, 2021

    Report

    Report Number
    3000931034-2021-00280
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 13, 2021
    Report Date
    December 23, 2021
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HWA
    UDI-DI
    03700386968969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: PLEASE REFER TO D9/H3 PRODUCT AVAILABLE TO STRYKER ; H4 MANUFACTURING DATE ; H6 METHOD CODE, RESULTS CODE, CONCLUSION CODE, AND HEALTH IMPACT CODE. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED. H3 OTHER TEXT : DEVICE DISCARDED.

    Description of Event or Problem · 0

    TIGHTENING BOLT ON INNER ROD HAD STRIPPED THREADS. MAKING IT IMPOSSIBLE TO ASSEMBLE WITH IMPACTOR HANDLE. THEREFORE MAKING IT IMPOSSIBLE TO ATTACH THE BASEPLATE TO THE IMPACTOR. SURGEON TRIED TO ASSEMBLE THE IMPACTOR WITH VISE GRIPS WITHOUT SUCCESS. NO BACK-UP DEVICE WAS AVAILABLE. THE SURGEON HAD TO HOLD THE BASEPLATE TIGHT WITH HIS FINGERS WHILE HAMMERING THE IMPACTOR. THIS CAUSED A 20 MINUTE DELAY.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    TIGHTENING BOLT ON INNER ROD HAD STRIPPED THREADS. MAKING IT IMPOSSIBLE TO ASSEMBLE WITH IMPACTOR HANDLE. THEREFORE MAKING IT IMPOSSIBLE TO ATTACH THE BASEPLATE TO THE IMPACTOR. SURGEON TRIED TO ASSEMBLE THE IMPACTOR WITH VISE GRIPS WITHOUT SUCCESS. NO BACK-UP DEVICE WAS AVAILABLE. THE SURGEON HAD TO HOLD THE BASEPLATE TIGHT WITH HIS FINGERS WHILE HAMMERING THE IMPACTOR. THIS CAUSED A 20 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902237 AEQUALIS REVERSED II UNIVERSAL GLENOID BASEPLATE IMPACTOR IMPACTOR HWA TORNIER S.A.S. GLENOID BASEPLATE IMPACTOR 10B803 03700386968969

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other