BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT F/LOCKCAP F/URS

    MDR report key: 3162578 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03286
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSISONE OF THE THREE POSITIONING CAMS COMPLETELY BROKE OFF AND IS MISSING FOR AN INVESTIGATION. WE ARE NOT ABLE TO RELIABLY DETERMINE THE CAUSE OF THIS BREAKAGE. IT IS POSSIBLE THAT THE INSTRUMENT WAS POSITIONED INCORRECTLY IN ITS COUNTERPART WHICH LED TO A MECHANICAL OVERLOADING SITUATION WITH THE BREAKAGE AS A RESULT. THIS ARTICLE WAS MANUFACTURED IN FEBRUARY 2009. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A SURGEON USED THE CAP-LOADING DRIVER TO UNLOCK THE CAPS WITH TIGHTENED SET SCREWS. AFTER SEVERAL TIMES OF CAPS LOADING, THE TOOTH OF THE CAP DRIVER SHAFT FOR THE CAPS WERE BROKEN. BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. ANOTHER CAP LOADING DRIVER WAS AVAILABLE FOR USE. THIS EVENT PROLONGATED THE SURGERY AROUND 10 MINS. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263323 SCRDRIVERSHAFT F/LOCKCAP F/URS HXX SYNTHES USA 3098655

    Patients

    Seq Age Sex Outcome Treatment
    1