BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE 188MM

    MDR report key: 7931133 · Received October 3, 2018

    Report

    Report Number
    2939274-2018-54127
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 13, 2018
    Report Date
    September 13, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982067371
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE EVALUATED BY MFR, DEVICE MANUFACTURE DATE: DHR REVIEW WAS COMPLETED. PART: 03.010.063; LOT: 3600510; MANUFACTURING SITE: HAEGENDORF; RELEASE TO WAREHOUSE DATE: 02.NOV.2010. 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 THE FOLLOWING INVESTIGATION FLOW WAS PERFORMED: DEVICE INTERACTION/FUNCTIONAL VISUAL INSPECTION: THE PROTECTION SLEEVE WAS RECEIVED AT US CQ SHOWING SIGNS OF USE (SCRATCHES AND SLIGHT DEFORMATIONS) BUT NOTHING THAT WOULD INHIBIT FUNCTION. FUNCTIONAL TEST: A 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 THEREFORE THE COMPLAINT DOES NOT AGREE WITH COMPLAINT CONDITION. DIMENSIONAL INSPECTION: DRAWING: OUTER Ø OF SHAFT: 11.98 +0/- 0.02 MM; INNER Ø OF DISTAL TIP: 8.1 +0.05/ -0 MM; MEASURED DIMENSIONS: OUTER Ø: 11.97 MM; CONFORMING; INNER Ø: LARGEST GAUGE PIN FIT 8.1 MM; CONFORMING; DEVICE USED: CALIPERS AND GAUGE PIN. A DEVICE HISTORY REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A REVIEW OF THE CURRENT DESIGN DRAWING AND THE DRAWING REVISION AT THE TIME OF MANUFACTURE WAS PERFORMED: TOP LEVEL AND NO ISSUES WERE IDENTIFIED. THE COMPLAINT CONDITION IS UNCONFIRMED AS THE INSTRUMENT SHOWED NO FUNCTIONAL DEFECTS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 · 1

    DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE RECON LOCKING AIMING ARM, PROTECTION SLEEVE, REAMER FOR HIP SCREWS (LATERAL FEMORAL NAIL) LFN AND INSERTION HANDLE FOR EXPERT TIBIAL NAIL AND FEMORAL NAIL (TN+FN) DID NOT ALIGN PROPERLY DUE TO WEAR AND TEAR OVER TIME. THE LOCKING OF THE LFN NAIL WAS BECOMING IMPOSSIBLE WITH THE DESIGNED TARGETING DEVICE. THE TARGETING DEVICE WAS AIMING AT THE LFN NAIL INSTEAD OF AT THE HOLE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE: LFN NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770697 12.0MM/8.0MM PROTECTION SLEEVE 188MM MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3600510 10886982067371

    Patients

    Seq Age Sex Outcome Treatment
    1