BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC REDUCTION FORCEPS

    MDR report key: 5704396 · Received June 7, 2016

    Report

    Report Number
    9680938-2016-10076
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    May 19, 2016
    Report Date
    May 19, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH/AGE AND WEIGHT ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. SERVICE HISTORY RECORD REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 398.88 WITH LOT NUMBER 5232294 IS A LOT/BATCH CONTROLLED ITEM. THE RELEASE TO WAREHOUSE DATE FOR THIS ITEM IS APRIL 29, 2006. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING DATE: JULY 27, 2005. THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS CONFIRMS THAT THE COMPONENTS AND FINAL PRODUCT MET ALL ACCEPTANCE CRITERIA. THE HARDNESS WAS MEASURED AS CONFORMING. THE RAW MATERIAL CERTIFICATION IS OVER 10 YEARS OLD AND THEREFORE, IS NOT AVAILABLE FOR REVIEW. ALL SIXTEEN (16) PARTS OF THE LOT WERE CHECKED 100%. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. DEVICE 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

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE ITEM BROKE AT THE SCREW JUNCTION. THE REPAIR TECHNICIAN REPORTED THE SCREW WAS BROKEN OFF AT THE BOX STUD, AND THE CORRECT PART REQUIRED TO REPAIR THE ITEM WAS NOT AVAILABLE. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS 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.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE PELVIC REDUCTION FORCEPS WERE RETURNED AND REPORTED TO HAVE BROKEN AT THE RIVET JUNCTION DURING SURGERY. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY ELEVEN (11) YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY AND/OR STERILE PROCESSING. HOWEVER, THIS COMPLAINT IS NOT LIKELY THE RESULT OF ANY DESIGN OR MANUFACTURING-RELATED DEFICIENCIES. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE PELVIC REDUCTION FORCEPS IS AN INSTRUMENT ROUTINELY USED WITH THE PELVIC REDUCTION INSTRUMENT SET. THE HINGE PIN, OR RIVET, AT THE CONNECTING POINT BETWEEN THE TWO FORCEPS ARMS HAS BROKEN OFF ALONG THE WELD THAT ATTACHES IT TO THE ARMS. THE DEVICE WAS MANUFACTURED IN JULY, 2005 AND IS ELEVEN YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE FAIRLY GOOD CONDITION WITH ONLY SOME MARKINGS AND SIGNS OF WEAR ALONG ITS LENGTH. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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 AS IT IS ALREADY BROKEN. DEVICE 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 A PAIR OF PELVIC REDUCTION FORCEPS BROKE AT THE RIVET JUNCTION DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE INTENDED TO TREAT AN ACETABULUM/PELVIS FRACTURE. THE RIVET BROKE INTO TWO PIECES, BOTH OF WHICH WERE RETRIEVED. AN ALTERNATE PAIR OF FORCEPS WAS READILY AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY; THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357622 PELVIC REDUCTION FORCEPS FORCEPS HTD SYNTHES TUTTLINGEN 5232294

    Patients

    Seq Age Sex Outcome Treatment
    1