BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 5717085 · Received June 10, 2016

    Report

    Report Number
    3000270450-2016-10133
    Event Type
    Malfunction
    Date Received
    June 10, 2016
    Report Date
    May 24, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INITIALS NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PART #314.291 / LOT #13-0748 MANUFACTURING LOCATION: (B)(4) SUPPLIER: (B)(4), MANUFACTURING DATE: 03.JUN.2013. 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

    IT WAS REPORTED THAT DURING A PROCEDURE, WHILE THE SURGEON WAS TIGHTENING THE COLLINEAR REDUCTION CLAMP, THE HANDLE BROKE OFF. THIS COMPLAINT INVOLVES ONE (1) DEVICE: COLLINEAR REDUCTION CLAMP WITH ONE PART DATA. THIS REPORT IS 1 OF 1 FOR (B)(4). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372460 SLIDING MECHANISM FORCEPS HTD SYNTHES SELZACH 13-0748

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR