BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS

    MDR report key: 8011154 · Received October 28, 2018

    Report

    Report Number
    2939274-2018-54651
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Date of Event
    September 13, 2018
    Report Date
    September 13, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWB
    UDI-DI
    10886982195883
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DHR REVIEW WAS COMPLETED. PART: 357.133 , LOT: L750831 , MANUFACTURING SITE: HAEGENDORF , RELEASE TO WAREHOUSE DATE: 06.MAR.2018 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. DAMAGE: VISUAL (APPEARANCE NOT AS EXPECTED) FLOW VISUAL INSPECTION: UPON VISUAL INSPECTION, THE COMPLAINT CONDITION WAS CONFIRMED, AS THREADS ON THE DISTAL END OF THE EXTRACTION SCREW WERE FOUND TO BE DAMAGED/STRIPPED DOES THE RECEIVED CONDITION AGREE WITH THE COMPLAINT DESCRIPTION? YES DIMENSIONAL INSPECTION: THE DIAMETER OF UNDAMAGED THREADS NEAR THE DAMAGED THREADS WAS MEASURED. INTENDED THREAD DIAMETER ACCORDING TO DRAWING IS BETWEEN 7.760 MM ¿ 7.972 MM MEASURED: 7.83 MM (CONFORMING) DOCUMENT/SPECIFICATION REVIEW: DRAWING SE_580137 WAS REVIEWED AND NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. WAS THE COMPLAINT CONFIRMED? YES . INVESTIGATION CONCLUSION: THE EVENT DESCRIPTION INDICATED THAT THE SURGEON DECIDED TO TRY AND USE THE EXTRACTION SCREW AND THE HAMMER GUIDE TO TRY AND ADVANCE THE NAIL, AFTER FACING CHALLENGES DURING NAIL INSERTION. IT IS POSSIBLE THAT NOT USING THE EXTRACTION SCREW AS INTENDED, EXPOSED THE THREADS TO UNINTENDED FORCES WHICH SUBSEQUENTLY CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: DEVICE MANUFACTURE DATE. DEVICE EVALUATED BY MFR, DEVICE MANUFACTURE DATE: A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. CORRECTED DATA: DATE OF EVENT. 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

    THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 THE PATIENT UNDERWENT INTRAMEDULLARY NAIL FIXATION ON (B)(6) 2018 DUE TO COMMINUTED MIDSHAFT FEMUR FRACTURE SUSTAINED FROM A GUNSHOT. THE SYNTHES FEMORAL RECON NAIL (FRN) WAS USED WITH RECON SCREWS TO ADDRESS THE FRACTURE PRESENTED. THE SURGEON FIRST REDUCED THE FRACTURE AND PASSED A GUIDE ROD. HE THEN REAMED TO 12.5MM AND SELECTED A RIGHT FRN NAIL FOR INSERTION. THE DRIVING CAP WAS THEN HAMMERED WITH A MALLET TO ADVANCE THE NAIL, BUT WHEN THE NAIL WAS APPROXIMATELY HALF WAY INSERTED, THE DRIVING CAP BROKE ABOVE THE THREADS THAT SCREW INTO THE INSERTION HANDLE. THE SURGEON USED THE EXTRACTION SCREW AND HAMMER GUIDE TO ADVANCE THE NAIL WHICH WAS UNSUCCESSFUL. THE SURGEON THEN DECIDED TO REMOVE THE NAIL AND CHANGE NAIL SYSTEMS DUE TO THE FRN THREADS BREAKING OFF INTO THE INSERTION HANDLE. THE SURGEON REAMED THE FEMORAL CANAL AGAIN AND REAMED THE PROXIMAL CANAL TO 15MM TO ACCOMMODATE A LATERAL ENTRY FEMORAL NAIL (LEFN) RECON NAIL. THE NAIL WAS INSERTED, SUCCESSFULLY, AND TWO RECON SCREWS WERE PLACED INTO THE HEAD OF THE FEMUR. ONE DISTAL INTERLOCKING SCREW WAS IMPLANTED TO CONTROL ROTATION. A SURGICAL DELAY OF 60 MINUTES WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPON RECEIPT AND INSPECTION OF DEVICES, IT WAS DISCOVERED THAT THE TIP OF THE EXTRACTION SCREW WAS DEFORMED AND STRIPPED. CONCOMITANT DEVICES: HAMMER GUIDE (PART: 03.010.170, LOT: UNKNOWN, QUANTITY: UNKNOWN); RADIOLUCENT INSERTION HANDLE FRN (PART: 03.033.001, LOT: L750729, QUANTITY: 1); TITANIUM FEMORAL RECON NAIL (PART: 04.033.170S, LOT: L902911, QUANTITY: 1) ; MALLET (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) EXTRACTION SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851874 EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS EXTRACTOR HWB WRIGHTS LANE SYNTHES USA PRODUCTS LLC L750831 10886982195883

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR