BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARROW SCREW REMOVAL PLIERS

    MDR report key: 4101782 · Received September 19, 2014

    Report

    Report Number
    3003862213-2014-10039
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    UMKIRCH
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE RETURNED PART WAS INVESTIGATED. THE INVESTIGATION CONFIRMS THAT ONE OF THE TIPS IS INDEED COMPLETELY BROKEN OFF. THE DAMAGE IS QUITE SEVERE AND THOUGH WE CANNOT DETERMINE THE EXACT ROOT CAUSE. BASED ON THE DAMAGE IT IS LIKELY THOUGH THAT SIMPLY EXCESSIVE MECHANICAL FORCE DURING THE SCREW REMOVAL FINALLY RESULTED IN THE BREAKAGE OF THE TIP. THOUGH THIS INSTRUMENT IS 8 YEARS OLD (MANUFACTURED AUGUST 2006), IT IS IN VERY GOOD CONDITION OTHERWISE. FURTHERMORE, A REVIEW OF THE PRODUCTION DOCUMENTS SHOWED THAT THIS INSTRUMENT WAS MANUFACTURED MEETING ALL SPECIFICATIONS. NO ACTUAL PRODUCT FAULT COULD BE FOUND. 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. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PLIERS WERE BEING USED TO REMOVE A SCREW, AND ONE OF THE TIPS OF THE PLIER SNAPPED OFF. PIECE 1.5CM LONG WAS EASILY RETRIEVED, AND NOTHING LEFT IN THE PATIENT. AN ALTERNATIVE PAIR OF PLIERS WERE LOCATED. PROCEDURE WAS DELAYED BY 1 MINUTE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584231 NARROW SCREW REMOVAL PLIERS PLIERS,SURGICAL HTC UMKIRCH 1530192

    Patients

    Seq Age Sex Outcome Treatment
    1