BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL

    MDR report key: 6685768 · Received July 5, 2017

    Report

    Report Number
    1719045-2017-10628
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    June 21, 2017
    Report Date
    June 21, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT/SERIAL NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. 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

    SYNTHES MANUFACTURING LOCATION & LOT NUMBER WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. UDI UPDATED. DHR REVIEW FOR PART #-356.543; LOT #-4072220. DHR REVIEW FOR PART#356.543 LOT#4072220. RELEASE TO WAREHOUSE DATE: 14-JUNE-2000. MANUFACTURED BY SYNTHES (B)(4). MRR 19914 WAS WRITTEN FOR PART#356.543 LOT#4072220 FOR SPOTTY FINISH ON 13 OF 30 INSPECTED PARTS. THE 13 PARTS WERE REWORKED (RE-CLEAN AND INSPECT) AND ALL WERE ACCEPTED. THIS MRR FOR VISUAL DEFECT (SPOTTY FINISH) IS NOT RELATED TO THIS COMPLAINT FOR DEVICE BREAKING. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE REPORT INDICATES THAT A: CUSTOMER QUALITY (CQ) ENGINEERING INVESTIGATION: THE DISTAL M6 THREADED TIP IS SHEARED OFF THE RETURNED DEVICE AS REPORTED. THE SHEARED OFF THREADED TIP FRAGMENT WAS NOT RETURNED TO CQ AND WOULD BE APPROXIMATELY 16.0MM LONG WITH REFERENCE TO DRAWING THAT WAS MADE TO REVISION C. THE MATERIAL SURFACE AT THE TRANSVERSE FRACTURE SITE APPEARS HOMOGENEOUS WHEN VIEWED UNDER 5X MAGNIFICATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE IS ALREADY BROKEN. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. MOST LIKELY THE MALFUNCTIONED WAS DUE TO SHEAR FORCES FROM OFF ANGLE BLOWS DURING SURGERY, AND OVER 17 YEARS OF USE HAS LED TO THIS CONFIRMED COMPLAINT FOR THE 356.543 EXTRACTION SCREW FOR TITANIUM TIBIAL NAILS, HOWEVER THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY.THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED, THEREFORE, THIS COMPLAINT IS CONFIRMED. 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

    PATIENT INFORMATION IS UNKNOWN. UDI: (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS IT WAS REPORTEDLY DISCARDED BY THE FACILITY. CONTACT PHONE NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THE FOLLOWING: AN EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL BROKE DURING A REVISION SURGERY OF THE LEFT TIBIA ON (B)(6) 2017. THE DEVICE BROKE DURING REMOVAL OF A TIBIAL NAIL. THE DEVICE WAS SCREWED INTO THE TOP OF THE NAIL AND THE DEVICE BROKE WHERE IT CONNECTS TO THE SCREW, WHILE TRYING TO EXTRACT THE NAIL. THE PIECE THAT BROKE OFF OF THE DEVICE WAS STUCK IN THE NAIL. THE BREAKAGE OF THE DEVICE WAS A CLEAN BREAK WITH NO FRAGMENTS. BOTH THE NAIL AND THE PIECE THAT WAS STUCK IN THE NAIL WERE REMOVED EASILY. THE REVISION SURGERY HAD BEEN REQUESTED BY THE PATIENT BECAUSE THE PATIENT WANTED A STAINLESS STEEL NAIL INSTEAD OF A TITANIUM NAIL. THERE WAS NO KNOWN MEDICAL REASON FOR THE REVISION. THE ORIGINAL SURGERY WAS FOR A LEFT TIBIAL FRACTURE WHICH OCCURRED AT AN UNKNOWN DATE ABOUT 20 YEARS AGO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF DELAY OR MEDICAL INTERVENTION. THE PATIENT'S POST-OPERATIVE STATUS WAS NOTED TO BE STABLE. CONCOMITANT DEVICE REPORTED: TIBIAL NAIL (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467257 EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 4072220

    Patients

    Seq Age Sex Outcome Treatment
    1 1 UNKNOWN TIBIAL NAIL