BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 6041541 · Received October 19, 2016

    Report

    Report Number
    9612488-2016-10425
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 30, 2016
    Report Date
    September 30, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE DRIVING CAP (PART NUMBER 03.010.523, LOT NUMBER 9065795). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE DRIVING CAP SHOWS REGULAR USE, WITH HAMMER MARKS AND GOUGES ON THE HEAD OF THE DEVICE CONSISTENT WITH HIGH IMPACT FORCE. THE DISTAL THREADED TIP OF THE OF THE DRIVING CAP IS BROKEN OFF AND WAS RETURNED STUCK IN THE RETURNED CONCOMITANT INSERTION HANDLE (PART #03.010.486, LOT # 9102620). ALTHOUGH THE EXACT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE DETERMINED, THE DAMAGE APPEARS TO BE THE RESULT OF HAMMERING ON THE DEVICE BEFORE IT WAS FULLY SEATED AGAINST THE INSERTION HANDLE. THE COMPLAINT IS CONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. DRAWINGS WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF RISK ASSESSMENT DESIGN AND CLINICAL RISK MANAGEMENT, FOUND THE RISK SPECIFIC TO THE COMPLAINT CONDITION ADEQUATELY ADDRESSED. 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. THE RISK ASSESSMENT ADEQUATELY ADDRESSES THE COMPLAINT EVENT. CALIPERS WERE USED FOR ALL DIMENSIONAL INSPECTIONS/MEASUREMENTS. THE RETURNED CONCOMITANT DEVICE IN THIS COMPLAINT RECORD SHOW NO EVIDENCE OF HAVING CONTRIBUTED TO THE EVENT, AND NO PRODUCT DESIGN OR MANUFACTURING RELATED ISSUE WAS IDENTIFIED WITH THESE CONCOMITANT DEVICES UPON A VISUAL INSPECTION. ALTHOUGH THE EXACT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE DETERMINED, THE DAMAGE APPEARS TO BE THE RESULT OF HAMMERING ON THE DEVICE BEFORE IT WAS FULLY SEATED AGAINST THE INSERTION HANDLE. 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. PATIENT AGE OR DATE OF BIRTH NOT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW WAS COMPLETED;(B)(4), MANUFACTURING DATE: 05. NOV. 2014. NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD 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

    IT WAS REPORTED THAT DURING A PROCEDURE FOR A TIBIA FRACTURE ON (B)(6) 2016, THE DRIVING CAP BROKE AND FELL INSIDE THE INSERTION HANDLE. THE SURGEON ENDED UP USING THE SAME INSTRUMENTS TO COMPLETE THE PROCEDURE. THERE WAS NO ALLEGATION AGAINST THE INSERTION HANDLE. PATIENT STATUS WAS REPORTED AS FINE. THERE WAS NO SURGICAL DELAY REPORTED AND SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE (PART# 03.010.486, LOT# 9102620, QTY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693161 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 9065795

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDLE (PART# 03.010.486, LOT# 9102620, QTY 1)