BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT REDUCTION FORCEPS FORLOW PROFILE PELVIC SYSTEM

    MDR report key: 5161845 · Received October 20, 2015

    Report

    Report Number
    9680938-2015-10098
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    October 6, 2015
    Report Date
    October 6, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE 03.100.020 STRAIGHT REDUCTION FORCEPS ARE AN INSTRUMENT ROUTINELY USED IN THE 3.5MM LOW PROFILE PELVIC SYSTEM REDUCTION INSTRUMENT SET. THE ASSOCIATED DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN INTRAOPERATIVELY. THIS CONDITION IS CONFIRMED; A HANDLE AT THE PROXIMAL END OF THE DEVICE HAS BROKEN OFF AT THE JUNCTION WITH THE SPEED LOCK ALONG A ROUGH FRACTURE SURFACE. IT IS LIKELY THAT OVER NINE YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN 6/2006 AND IS OVER NINE YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION WITH SOME DISCOLORED MARKINGS ALONG THE LENGTH OF THE DEVICE. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE SYNTHES LOT NUMBER FOR THE SUBJECT DEVICE IS 5272826. THE PREVIOUSLY REPORTED LOT NUMBER AND THE LOT NUMBER ETCHED ON THE SUBJECT DEVICE, A7PA24, IS THE SUPPLIER LOT NUMBER. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW 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 #904586 AND #0815 IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AT 47,3 HRC AND WAS FOUND TO BE GOOD. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE SUBJECT DEVICE IS ENTERING THE COMPLAINT SYSTEM 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 AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT ACETABULUM, WHILE APPLYING A CLAMP, ONE SIDE OF THE HANDLE BROKE OFF AT THE LOCKING MECHANISM ON THE SET OF STRAIGHT REDUCTION FORCEPS WITH POINTED BALL TIPS. AN ALTERNATE CLAMP WAS AVAILABLE. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690980 STRAIGHT REDUCTION FORCEPS FORLOW PROFILE PELVIC SYSTEM FORCEPS HTD SYNTHES TUTTLINGEN 5272826

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR