BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS

    MDR report key: 5007936 · Received August 17, 2015

    Report

    Report Number
    9612488-2015-10417
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 31, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 12 DECEMBER 2014. NO NON-CONFORMANCE REPORTS 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. 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. ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 309.530, CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS, LOT NUMBER 9240224). THE SUBJECT DEVICE WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER ETCHING WAS EASILY READABLE. THE THREAD OF THE INSTRUMENT IS BROKEN. AS PREVIOUSLY REPORTED, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE RELEVANT PARAMETERS HARDNESS AND DIAMETER OF THE SHAFT WERE MEASURED AND FULFILLED THE REQUIREMENTS. THE DIMENSIONS OF THE THREAD COULD NOT BE DETERMINED, DUE TO THE DAMAGE OF THE PRODUCT. THE ITEM IS AN EXTRACTION SCREW, WHERE DEPENDING ON THE ISSUE HEAVY FORCES CAN BE APPLIED. THEREFORE IT IS HIGHLY PROBABLE THAT THE DAMAGE OCCURRED DURING THE USE OF THE INSTRUMENT, ESPECIALLY SINCE DURING PRODUCTION (DHR) AND IN THE MEASURED DIMENSIONS (SHAFT DIAMETER AND HARDNESS) NO ABNORMALITIES WERE DETECTED. BASED ON THE RESULTS OF THE INVESTIGATION THE COMPLAINT CONDITION WAS CONFIRMED (SINCE THE SCREW WAS FOUND BROKEN). SINCE NO FAILURES IN THE DHR AND IN THE MEASURED PARAMETERS WERE FOUND, THE COMPLAINT IS RATED AS NOT VALID FROM A MANUFACTURING PERSPECTIVE. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE EXTRACTION SURGERY OF A LOCKING SCREW WAS PERFORMED AT PROXIMAL TIBIA IN THE PATIENT. A LOCKING SCREW WAS ATTEMPTED TO BE EXTRACTED FROM THE IMPLANTED PLATE. DURING THE SURGERY, THE SURGEON OPTED TO APPLY THE CONICAL EXTRACTION SCREW IN QUESTION TO EXTRACT THE LOCKING SCREW. HOWEVER, THE TIP OF THE REPORTED CONICAL EXTRACTION SCREW BROKE AND KEPT ENGAGED WITH THE HEAD OF THE LOCKING SCREW. EVENTUALLY, THE SURGEON ABANDONED TO EXTRACT THE LOCKING SCREW AND PRUNED THE IRREMOVABLE SCREW HEAD AWAY BY USE OF A CARBIDE DRILL. THE SURGERY WAS EXTENDED FOR SOME MINUTES YET THE SPECIFIC TIME WAS NOT REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542764 CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS EXTRACTOR HWB SYNTHES BETTLACH 9240224

    Patients

    Seq Age Sex Outcome Treatment
    1