BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEK ZIP SUTURE ANCHOR, 5.5MM

    MDR report key: 3133180 · Received May 29, 2013

    Report

    Report Number
    0002936485-2013-00226
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MBI
    PMA / PMN Number
    K070758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 REPORTED FAILURE MODE WAS CONFIRMED UPON VISUAL INSPECTION OF THE RETURNED UNIT. THE TIP OF THE INSERTER ASSEMBLY HAD BROKEN OFF AT THE WELDING AREA. HOWEVER, THE BROKEN PIECE WAS NOT RETURNED FOR EVALUATION. THE DISTAL END OF THE TUBE ASSEMBLY APPEARED SLIGHTLY BENT. REVIEW OF THE DEVICE HISTORY RECORD FOR THE SUBJECT PART AND LOT NUMBER DISCLOSED NO DISCREPANCIES THAT COULD BE ASSOCIATED TO THE REPORTED ISSUE. PROBABLE ROOT CAUSE(S) FOR THE REPORTED FAILURE COULD BE ATTRIBUTED, BUT NOT LIMITED TO: WELDING ISSUES (E.G. INCOMPLETE/OFF-CENTERED) AND/OR EXCESSIVE TORQUE EXERTED ON THE DEVICE DURING INSERTION (USER). 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 TIP OF THE DEVICE BROKE OFF AND WAS LATER REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE DEVICE BROKE OFF AND WAS LATER REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236756 PEEK ZIP SUTURE ANCHOR, 5.5MM FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI STRYKER ENDOSCOPY-SAN JOSE 12031AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR