BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/

    MDR report key: 2923188 · Received January 18, 2013

    Report

    Report Number
    8030965-2013-00183
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. UNFORTUNATELY THE SCHANZ SCREW WAS NOT RETURNED IN ORDER TO COMPREHEND THE MENTIONED PROBLEM. AS THIS IS A VERY OLD INSTRUMENT, WE SUPPOSE THAT THE DAMAGES WERE CAUSED DUE TO NORMAL WEAR AND TEAR OVER THE YEARS. THE MANUFACTURING DOCUMENTS WHERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WHERE FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    WHILE CUTTING A SHANZ PIN INTRA-OPERATIVELY THE PIN BECAME COLD WELDED TO THE BOLT CUTTING HEAD AND COULD NOT BE REMOVED. THE BOTTOM OF THE DEVICE BROKE OFF. THIS IS # 1 OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27650 BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/ BOLT CUTTING HEAD LXH SYNTHES GMBH 1105229

    Patients

    Seq Age Sex Outcome Treatment
    1 SHANZ PIN