BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP HOLDING FORCEPS

    MDR report key: 4003942 · Received August 12, 2014

    Report

    Report Number
    9680938-2014-10049
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE RIB HOOK CAP HOLDER HAS SHEARED OFF AT BOTH TIPS. OTHERWISE THERE IS NO SIGN OF MISUSE ON THIS INSTRUMENT. THE MANUFACTURING EVALUATION SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A HARDNESS TEST WAS CARRIED OUT AND FOUND TO BE CONFORMING. 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

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT #904793 AND 904798 IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AT 48 HRC AND WAS FOUND TO BE GOOD. 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 THAT THE TIPS OF CAP HOLDING FORCEPS SHEARED OFF INTRA-OPERATIVELY. IT WAS REPORTED THAT THE SURGEON PERFORMED A PLANNED VEPTR II REVISION ON (B)(6) 2014. DURING SURGERY, WHILE AT THE BACK TABLE, THE SURGEON WAS USING THE CAP HOLDING FORCEPS TO HOLD THE TOP HALF OF THE HOOK AND USING AND USING A SMALL FRAGMENT PLATE BENDER TO BEND THE HOOK. IT WAS REPORTED THAT THE TIPS OF THE FORCEPS SHEARED RIGHT OFF. A BACK UP INSTRUMENT, FORCEPS, WAS AVAILABLE. NO SURGERY DELAYS OR HARM TO PATIENT WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480260 CAP HOLDING FORCEPS FORCEPS HTD SYNTHES TUTTLINGEN T924960

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR