BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIC-INSTR F/STERNAL ZIPFIX

    MDR report key: 6749060 · Received July 27, 2017

    Report

    Report Number
    3003875359-2017-10354
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Report Date
    July 11, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    JDQ
    UDI-DI
    07611819418424
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE AVAILABLE FOR EVALUATION?: DATE RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART #03.501.080 / LOT #9150675, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 10 OCT 2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION ACTION/SUMMARY WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT: DURING THE MANUFACTURING INVESTIGATION, IT'S BEEN OBSERVED THAT PIN Ø3 X 15 MM, COMPONENT 60069576, IS NOT AT THE ORIGINAL POSITION. IN ACCORDANCE TO THE ASSEMBLY DRAWING, THE PIN SHOULD BE POSITIONED AND SECURED BY A LASER WELDING SEAM. THIS LASER WELDING SEAM IS MISSING ON BOTH SIDES OF THE PIN. THEREFORE, IT WAS POSSIBLE THAT THE PIN WAS MOVING AND BLOCKED THE LEVER FROM CORRECT OPERATING. THE COMPONENT LEVER AT LASER WELDING OPERATION WAS NOT DONE CORRECTLY. IN TOTAL, 3 PINS ARE GETTING LASER WELDED. TWO (2) PINS, ARE LASER WELDED CORRECTLY AND ON 1 PIN THE LASER WELDING SEAM ON BOTH SIDES IS MISSING. THE COMPLAINT IS DETERMINED TO BE MANUFACTURING RELATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE APPLICATION INSTRUMENT F/STERNAL ZIPFIX WAS SUBMITTED FOR REPAIR FROM AFFILIATE IN (B)(4). THERE WERE NO INJURIES, PATIENT USER INVOLVEMENT OR SURGERY DELAY OR NEED FOR ADDITIONAL MEDICAL INTERVENTION REPORTED. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528216 APPLIC-INSTR F/STERNAL ZIPFIX CERCLAGE FIXATION JDQ SYNTHES HAGENDORF 9150675 07611819418424

    Patients

    Seq Age Sex Outcome Treatment
    1