BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM

    MDR report key: 3789703 · Received May 5, 2014

    Report

    Report Number
    9680938-2014-10015
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A HARDNESS TEST WAS PERFORMED AND FOUND TO BE CONFORMING @47 HRC. THE DEVICE IS APPROX. 6 YEARS OLD. USED DRAWINGS / REVISION 399.78_C. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: LOT #5874803/T924779 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 11-SEP-2008. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE ONE OF THE TIPS BROKE OFF. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON (B)(4) 2014. THIS EVALUATION IS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 THE ITEM BROKE IN HALF WHILE BEING USED BY THE SURGEON DURING SURGERY; ONE OF THE HOOKS COMPLETELY BROKE OFF. ALL THE PARTS WERE RETRIEVED. THE SURGEON HAD ANOTHER CLAMP THAT WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT AND WITH NO ADVERSE EVENT TO THE PATIENT AND NO DELAY IN THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266419 REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM FORCEPS HTD SYNTHES TUTTLINGEN 5874803/T924779

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR