BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACK MAMBA SUTURE PASSER

    MDR report key: 7007517 · Received November 7, 2017

    Report

    Report Number
    0001825034-2017-09986
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    August 13, 2014
    Report Date
    November 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION DUE TO BEING DISCARDED. THE PRODUCT THAT EXHIBITED THE FAILURE MODE WAS REPRODUCED USING NEEDLES AND A SILICONE MEMBRANE TO SUBSTITUTE AS THE TISSUE. BY USING THIS SET UP THE, FRACTURE WAS RECREATED IN THE SAME LOCATION. FURTHER INVESTIGATION OF THE NEEDLE DID NOT REVEAL ANY DIMENSIONAL PROBLEMS OR MANUFACTURING DEFECTS FOR THE NEEDLE. ANALYSIS OF THE PASSER SHOWED THAT NEEDLE TRACK WAS BIASED TO FAR TO ONE SIDE. THIS WOULD ALLOW THE NEEDLE TO COME OUT OF IT'S TRACK AND TWIST. THIS INCREASED THE RESISTANCE OR FORCE REQUIRED TO "PUSH" THE NEEDLE THROUGH THE TISSUE. THIS FURTHER SUPPORTS THE EVIDENCE THAT THE NEEDLE IS UNDER HIGH COMPRESSION CAUSING THE NEEDLE TO BUCKLE/BREAK. REVIEW OF THE DHR FOUND UNITS WERE RELEASED FOR DISTRIBUTION WITH NO DEVIATION OR ANOMALY. REVIEW OF COMPLAINT HISTORY IDENTIFIED ASSOCIATED COMPLAINT AND A TREND WHICH WAS ADDRESSED THROUGH INTERNAL CONTROLS. THE ROOT CAUSE WAS DETERMINED TO BE ASSOCIATED WITH FAILURE DURING DESIGN VERIFICATION, FAILURE TO IMPLEMENT APPROPRIATE INSPECTION TECHNIQUES, AND INCORRECT PRINTS FROM VENDOR. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:09985.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2014 UTILIZING A SUTURE PASSER. DURING THE PROCEDURE, THE NITINOL NEEDLE FRACTURED INSIDE THE MAMBA SUTURE PASSER. A BIPASS SUTURE PASSER WAS USED TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY. THERE WAS NO INJURY TO THE PATIENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785908 BLACK MAMBA SUTURE PASSER PASSER HWQ ZIMMER BIOMET, INC. N/A 169620

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR