BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER REELX STT

    MDR report key: 3081582 · Received April 29, 2013

    Report

    Report Number
    0002936485-2013-00179
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. THE PROXIMAL END OF THE ANCHOR REMAINS ATTACHED TO THE INSERT. THE PEEK ANCHOR SHELL IS BROKEN RIGHT BELOW THE INTERNAL STAINLESS STEEL RATCHET COMPONENT. SOME OF THE PEEK SHELL IS BROKEN AWAY AROUND THE RATCHET. THE NOSE CONE, STEEL TIP AND HALF OF THE APERTURE ARE MISSING. IT WAS REPORTED THAT THE PATIENT IN THIS CASE HAD VERY HARD BONE QUALITY. THE ANCHOR WAS TESTED DURING IN A VARIETY OF BONE AND BONE ANALOGS USED TO REPRESENT THE MAJORITY OF BONE THAT THE ANCHOR WOULD BE INSERTED. HOWEVER, IT IS POSSIBLE THAT THE BONE IN THIS CASE WAS EXCEPTIONALLY HARD, AND CONTRIBUTED TO THE FAILURE OF ANCHOR BREAKAGE BY PLACING EXCESSIVE FORCE ON THE ANCHOR OR NOT IMPACTING THE ANCHOR PERPENDICULAR TO THE BONE. THE FAILURE MODE OF ANCHOR BREAKAGE WAS ONLY ABLE TO BE REPLICATED WHEN BOTH USER MISUSE AND HARD BONE WERE PRESENT. THUS HARD BONE IS CONSIDERED A CONTRIBUTING ROOT CAUSE TO THE FAILURE. THE INSTRUCTIONS FOR USE, SUGGESTS TO THE USER THAT A DRILL OR AWL MAY BE USED TO AID IN ANCHOR INSERTION IN CASES OF HARD BONE AND THE COMPANY REPRESENTATIVE INDICATED THE SURGEON DID USE A 6.5MM BIOZIP AWL. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE BROKE AND CRACKED WHILE BEING IMPLANTED. PIECES WERE REMOVED AND A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE BROKE AND CRACKED WHILE BEING IMPLANTED. PIECES WERE REMOVED AND A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184588 STRYKER REELX STT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI STRYKER ENDOSCOPY-SAN JOSE 02L1202336

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR