BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS

    MDR report key: 5880711 · Received August 16, 2016

    Report

    Report Number
    3003875359-2016-10448
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 2, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE IS UNKNOWN IF SURGERY WAS AN IMPLANT/EXPLANT. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE 510K#UNKNOWN. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: 03.010.000 / 7772210 MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23TH FEBRUARY 2012. NO DEVIATION OR ANY NCRS WERE MARKED IN THIS DOCUMENT. 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 MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED /PERFORMED. THE CONCLUSION INDICATES THAT: RECEIVED 1 ARTICLE OF EXTRACTSCR F/TIBIAL+FEM NAILS, ART. NO.: 03.010.000, FOR MANUFACTURING INVESTIGATION. THE ARTICLE IS IN A USED CONDITION. THE COATED M8 THREAD IS DAMAGED AND AS WELL THE AREA AROUND THE HEXAGONAL 11MM AT THE HEAD OF THE SCREW. THE COATED M8 THREAD WHICH GETS CONNECTED TO THE NAIL IMPLANT IS STRONGLY DAMAGED. OTHER DAMAGES WERE FOUND CLOSE TO THE HEAD OF EXTRACTSCR F/TIBIAL+FEM NAILS, DURING MANUFACTURING INVESTIGATION, BOTH THREADS ON THE EXTRACTSCR F/TIBIAL+FEM NAILS 03.010.000 HAS BEEN TESTED. THE COATED M8 THREAD IS OUT OF SPECIFICATION, GO AND NO-GO THREAD RING GAGES DID NOT PASS THE OUTSIDE THREAD. ACCORDING TO DRAWING SE_ THE SHAFT WITH THE M8 THREAD HAS BEEN HEAT TREATED DURING PRODUCTION. THE HARDNESS HAS BEEN MEASURED AND IT MEETS REQUIREMENT. 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 MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED /PERFORMED. THE CONCLUSION INDICATES THAT: RECEIVED 1 ARTICLE OF EXTRACTSCR F/TIBIAL+FEM NAILS, ART. NO.: 03.010.000, FOR MANUFACTURING INVESTIGATION. THE ARTICLE IS IN A USED CONDITION. THE COATED M8 THREAD IS DAMAGED AND AS WELL THE AREA AROUND THE HEXAGONAL 11MM AT THE HEAD OF THE SCREW. THE COATED M8 THREAD WHICH GETS CONNECTED TO THE NAIL IMPLANT IS STRONGLY DAMAGED. OTHER DAMAGES WERE FOUND CLOSE TO THE HEAD OF EXTRACTSCR F/TIBIAL+FEM NAILS, DURING MANUFACTURING INVESTIGATION, BOTH THREADS ON THE EXTRACTSCR F/TIBIAL+FEM NAILS 03.010.000 HAS BEEN TESTED. THE COATED M8 THREAD IS OUT OF SPECIFICATION, GO AND NO-GO THREAD RING GAGES DID NOT PASS THE OUTSIDE THREAD. ACCORDING TO DRAWING SE_ THE SHAFT WITH THE M8 THREAD HAS BEEN HEAT TREATED DURING PRODUCTION. THE HARDNESS HAS BEEN MEASURED AND IT MEETS REQUIREMENT. IT IIS LIKELY THAT THE DAMAGES ON THE EXTRACTSCR F/TIBIAL+FEM NAILS 03.010.000 ARE CAUSED BY MISHANDLING DURING MOUNTING/DISMOUNTING OF THE NAIL IMPLANT. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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

    (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY FOR FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2016, THE SURGEON COULD NOT ATTACH THE REPORTED EXTRACTION SCREW TO EXPERT TIBIAL NAIL (ETN) WHEN HE ATTEMPTED TO REMOVE THE NAIL. THE REMOVAL OF THE ETN AND THE SURGERY WAS COMPLETE SUCCESSFULLY. THE SURGERY WAS EXTENDED FOR 20 MINUTES DUE TO THE EVENT. IT IS NOT KNOWN IF IT WAS AN INITIAL OR A REVISION SURGERY. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PART: 1X ELASTIC TIBIAL NAIL (PART AND LOT NUMBER UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533387 CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS EXTRACTOR HWB SYNTHES HAGENDORF 7772210

    Patients

    Seq Age Sex Outcome Treatment
    1