BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0

    MDR report key: 2974840 · Received February 22, 2013

    Report

    Report Number
    8030965-2013-00611
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE ADAPTER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. WE FOUND THAT AROUND ON THE ADAPTER SHAFT ARE BADLY DAMAGED AND SHOW CLEARLY VISIBLE STRESS MARKS. THE EXCESSIVE DAMAGE TO THE SHAFT INDICATES THAT THE RECEPTACLES OF THE ADAPTER WAS ON THE WHOLE SHAFT AND WAS NOT AT THE DESIGNATED THREE INTERFACE COUPLING END. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SHAFT OF THE K-WIRE ADAPTOR USED IN PROCEDURES PREVIOUSLY, WAS WORN AND EXHIBITED GROOVES. IT WAS REPORTED THE ADAPTOR WAS USED APPROXIMATELY 10 TIMES. THIS IS 1 OF 1 REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77727 ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0 ADAPTER HXS SYNTHES GMBH 2598684

    Patients

    Seq Age Sex Outcome Treatment
    1