BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

    MDR report key: 9899675 · Received March 30, 2020

    Report

    Report Number
    2939274-2020-01605
    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
    FZX
    UDI-DI
    10886982068569
    PMA / PMN Number
    EXEMPT
    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE DEVICE SHOWS NORMAL WEAR WITH FEW SCRATCHES ON THE SURFACE 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 INSERTING THE CONNECTING SCREW INTO INSERTION HANDLE. THE CONNECTING SCREW WAS INSERTED PROPERLY INTO INSERTION HANDLE. FURTHER FUNCTIONAL TEST CANNOT BE PERFORMED AT CQ WITH THE AVAILABLE EQUIPMENT. DIMENSIONAL INSPECTION (CALIPERS: CA802): DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE THREADED DIAMETER OF THE DISTAL TIP OF THE DEVICE WAS MEASURED AND IS WITHIN SPECIFICATION AS PER THE RELEVANT DRAWING. DOCUMENT/ SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; CANNULATED CONNECTING SCREW WITH INTERNAL M6X1 THREAD NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: VISUAL INSPECTION, FUNCTIONAL INSPECTION, DIMENSIONAL INSPECTION, AND DOCUMENT SPECIFICATION REVIEW OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE COMPLAINT CANNOT BE CONFIRMED AS THE FULL FUNCTIONAL TEST COULD NOT BE PERFORMED AND REPLICATE THE COMPLAINT CONDITION. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE REPEATED USE AND SERVICE MIGHT HAVE CONTRIBUTED TO THE SCRATCHES ON THE SURFACE OF THE DEVICE. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 03.010.404, SYNTHES LOT NUMBER: U261953, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 21APR2017, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 MARCH 9, 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: AIMING ARM FOR SUPRAPATELLAR (PART NUMBER 03.010.441, LOT 170039-202, QUANTITY 1), INSERTION HANDLE SUPRAPATELLAR (PART NUMBER 03.010.440, LOT 180183-101, 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) CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362926 CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.404 U261953 10886982068569

    Patients

    Seq Age Sex Outcome Treatment
    1 AIMING ARM FOR SUPRAPATELLAR| INSERTION HANDLE FOR SUPRAPATELLAR| UNK - DRILL BITS: TRAUMA| UNK - NAILS