BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 9899742 · Received March 30, 2020

    Report

    Report Number
    2939274-2020-01606
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 9, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982068828
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: INSERTION HANDLE FOR SUPRAPATELLAR WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE DEVICE SHOWS NORMAL SURFACE WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. FUNCTIONAL TEST: FUNCTIONAL TESTING OF THE DEVICE WAS PERFORMED AT CQ BY TIGHTENING THE THUMB SCREW INTO INSERTION HANDLE THROUGH THE AIMING ARM. THE THUMB SCREW WAS INSERTED PROPERLY AND TIGHTENED INSERTION HANDLE WITH AIMING ARM. FURTHER FUNCTIONAL TEST CANNOT BE PERFORMED AT CQ WITH THE AVAILABLE EQUIPMENT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE INNER THREADED DIAMETER OF THE SCREW HOLE FOR THE THUMB SCREW ON INSERTION HANDLE WAS MEASURED AND IS WITHIN SPECIFICATION AS PER THE RELEVANT DRAWING AND ASME B1.13M-2005 METRIC SCREW THREADS, THREAD PROFILE WAS ALSO REVIEWED. DOCUMENT/ SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; INSERTION HANDLE, SUPRAPATELLAR ASME B1.13M-2005 METRIC SCREW THREADS, THREAD PROFILE WAS ALSO REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: VISUAL INSPECTION, FUNCTIONAL TEST, DIMENSIONAL INSPECTION, AND DOCUMENT SPECIFICATION REVIEW OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE COMPLAINT CANNOT BE CONFIRMED AS THE FUNCTIONAL TEST COULD NOT BE PERFORMED AND REPLICATE THE COMPLAINT CONDITION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED FAILURE. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. A MANUFACTURING RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE NO MANUFACTURING RECORD EVALUATION IS REQUIRED. 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 HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHILE THE SURGEON WAS USING THE AIMING ARM FOR SUPRAPATELLAR FOR PROXIMAL INTERLOCKS ON AN EXPERT TIBIAL NAIL, THE DRILL MISSED THE LOCKING HOLE THROUGH THE TARGETED GUIDE AND HIT THE NAIL. THE GUIDE AND DRILL WERE REMOVED BY UTILIZING THE PERFECT CIRCLES TECHNIQUE. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE.CONCOMITANT DEVICES REPORTED: CANN CONNECTIONS SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX(PART NUMBER 03.010.404, LOT U261953, QUANTITY 1), AIMING ARM FOR SUPRAPATELLAR (PART NUMBER 03.010.441, LOT 170039-202, QUANTITY 1), , DRILL BITS:TRAUMA (UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1), NAILS (UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1).THIS REPORT INVOLVES ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR.THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364517 INSERTION HANDLE FOR SUPRAPATELLAR NAIL,FIXATION,BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 180183-101 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1 AIMING ARM FOR SUPRAPATELLAR| CANN CONNECTING INSTRUMENTS| UNK - DRILL BITS: TRAUMA| UNK - NAILS