BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPS

    MDR report key: 5554461 · Received April 7, 2016

    Report

    Report Number
    9680938-2016-10043
    Event Type
    Malfunction
    Date Received
    April 7, 2016
    Report Date
    March 23, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HWN
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION SUMMARY - THE COMPLAINT CONDITION FOR THE 03.211.400 LOT NUMBER T950761 COMPRESSION FORCEPS WAS LIKELY CAUSED BY OVER FIVE YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING. CONVERSELY, THE COMPLAINT IS LIKELY NOT THE RESULT OF ANY DESIGN RELATED DEFICIENCY. THE 03.211.400 COMPRESSION FORCEPS IS AN INSTRUMENT ROUTINELY USED IN THE 2.4MM / 2.7MM VARIABLE ANGLE LCP FOREFOOT / MIDFOOT SYSTEM. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BEEN FOUND BROKEN. THIS CONDITION IS CONFIRMED; THE LEAF SPRING BETWEEN THE HANDLES OF THE DEVICE HAS FRACTURED AT THE SET SCREW WHICH FIXATES THE SPRING TO THE HANDLE. IT IS LIKELY THAT OVER FIVE YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN 11/2010 AND IS OVER FIVE YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE GOOD WORKING CONDITION SHOWING ONLY MINIMAL WEAR. THE DEVICE DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING DATE: 15-NOV-2010, PART #03.211.400, LOT# T950761. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE MATERIAL, COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS, CERTIFICATION TEST VALUES AND ACCEPTANCE CRITERIA. HRC ARE CORRESPONDING TO THE SPECIFICATIONS. NO NCRS WERE GENERATED DURING PRODUCTION. 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 WHILE RESTOCKING THE TRAY IT WAS NOTICED THAT THE DEVICE HAD BROKEN. THERE IS AN ARM INSIDE OF THE TWO MAIN ARMS, THE TENSION ARM THAT BROKE NEAR THE SCREW HOLE. SALES CONSULTANT CONFIRMS THAT THERE IS NO CASE OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT S 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216243 COMPRESSION FORCEPS INSTRUMENT COMPRESION HWN SYNTHES TUTTLINGEN T950761

    Patients

    Seq Age Sex Outcome Treatment
    1