BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW ATTACHMENT FOR TRAUMA RECON SYSTEM

    MDR report key: 2991996 · Received March 7, 2013

    Report

    Report Number
    8030965-2013-00759
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING TOTAL HIP REPLACEMENT PROCEDURE, THE SAW SOUNDED DIFFERENT THAN USUAL, CUT INTERMITTENTLY, AND THEN STOPPED CUTTING. A REPLACEMENT PART WAS SWAPPED OUT AND WORKED FINE WITH THE SAME MODULAR HAND PIECE. THE PROCEDURE WAS COMPLETED USING THE REPLACEMENT PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97396 RECIPROCATING SAW ATTACHMENT FOR TRAUMA RECON SYSTEM HWE SYNTHES GMBH 1671

    Patients

    Seq Age Sex Outcome Treatment
    1