BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 3201052 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-03891
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES ANSPACH. THE CUSTOMER''S COMPLAINT THAT THE DEVICE WAS TWISTING DURING USE WAS CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED WHICH CONFIRMED THAT THE STRAINING RING IS OUT OF ALIGNMENT. IT WAS REPORTED THAT THIS IS DUE TO NORMAL WEAR OVER TIME.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    Description of Event or Problem · 1

    FACILITY REPORTS, THE QUICK COUPLING FOR K-WIRES WAS TWISTING WHILE BEING USED IN AN UNKNOWN PROCEDURE. IT IS ALSO REPORTED THAT DEVICES FREEZE AND IS CROOKED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301713 QUICK COUPLING FOR K-WIRES HWE SYNTHES GMBH 10200

    Patients

    Seq Age Sex Outcome Treatment
    1