BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND F/355.220

    MDR report key: 3230385 · Received July 16, 2013

    Report

    Report Number
    8030965-2013-04373
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    May 22, 2013
    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

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

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE ADDITIONAL EVALUATION SHOW THAT IT IS CLEARLY VISIBLE THE FIRST TWO PITCHES OF THE THREAD ARE DAMAGED (355.220). THIS LEAD US BELIEVE THAT THE THREAD HAS NOT BEEN SUFFICIENTLY SCREWED INTO ARTICLE 355.280 AND SUBSEQUENTLY GOT DAMAGED DURING HAMMERING. WE ARE NOT ABLE TO RELIABLY DETERMINE THE CAUSE OF THE DAMAGE BUT IT APPEARS, THAT INADEQUATE HANDLING HAS LEAD TO THIS COMPLAINT. FURTHER INVESTIGATION REGARDING MANUFACTURING- AND MATERIAL DOCUMENTS SHOW NO DEVIATION TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE INSTRUMENT WILL ONLY TURN TWICE BEFORE IT STARTS CROSS THREADING. REPORTEDLY, IT APPEARS THAT THE THREAD PITCH ON THIS ITEM IS NOT CORRECT. SURGEON WAS UNABLE TO USE OUR SET TO REMOVE NAIL DUE TO THIS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329039 HAND F/355.220 LXH SYNTHES GMBH 13-5471

    Patients

    Seq Age Sex Outcome Treatment
    1