BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR RETROGRADE STANDARD LOCKING

    MDR report key: 7541536 · Received May 24, 2018

    Report

    Report Number
    2939274-2018-52300
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    May 5, 2018
    Report Date
    May 5, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982067227
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NO.: 03.010.050, LOT NO.: 1911585: MANUFACTURING LOCATION: HAEGENDORF, RELEASE TO WAREHOUSE DATE: 07.JUL.2008: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. FLOW: DEVICE INTERATION/FUNCTIONAL: VISUAL INSPECTION: THE DEVICE (PART 03.010.050, LOT 1911585, MFG 07.JUL.2008) WAS RECEIVED AT US CQ WITH NO VISIBLE SIGNS OF USE OR DAMAGE. FUNCTIONAL TEST: THE AIMING ARM WAS ABLE TO ASSEMBLE WITH MATING INSERTION HANDLE, HOWEVER A FULL FUNCTIONAL TEST COULD NOT BE PERFORMED AS FULL INTRAOPERATIVE CONDITIONS COULD NOT BE RECREATED DUE TO ALL MATING DEVICES NOT BEING RETURNED. THE COMPLAINT WAS NOT ABLE TO BE REPLICATED THEREFOR THE COMPLAINT DOES NOT AGREE WITH COMPLAINT CONDITION. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS COMPLETED, THE DIAMETER OF THE BORES WERE MEASURED USING GAUGE PINS. THE PROXIMAL BORE AND THE DISTAL BORE MEASURED AND IS WITHIN SPECIFICATION BASED ON THE RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWING(S) WAS REVIEWED. CONCLUSION: THE COMPLAINT CONDITION IS UNCONFIRMED AS THE AIMING ARM WAS RECEIVED WITHIN SPECIFICATION. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE REPORTED MISALIGNMENT WAS DUE TO OPERATIONAL CONTEXT. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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. DATE OF REPORT /DATE REC¿D BY MFR : INITIALLY REPORTED AS MAY 04, 2018, BUT SHOULD BE MAY 05, 2018. 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 · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, THE LONG DRILL BIT WAS HITTING THE NAIL WHEN DRILLING FOR THE TARGETED DISTAL INTERLOCK. THE SURGEON WAS ABLE TO PASS THE DRILL BIT THROUGH, BUT IT STILL WAS HITTING THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A TWO-FIVE (2-5) MINUTE SURGICAL DELAY. THE PATIENT WAS STABLE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER IS SYNTHES SALES CONSULTANT. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE 4.2MM DRILL BIT WAS HITTING THE NAIL WHEN DRILLING FOR THE TARGETED DISTAL INTERLOCK. SURGEON WAS ABLE TO PASS THE DRILL BIT THROUGH, BUT IT STILL HIT THE NAIL. NO PATIENT CONSEQUENCE OR SURGICAL DELAY WAS REPORTED. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE STANDARD LOCKING THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384277 AIMING ARM FOR RETROGRADE STANDARD LOCKING GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1911585 10886982067227

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR