BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN

    MDR report key: 8945846 · Received August 29, 2019

    Report

    Report Number
    2939274-2019-60209
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 1, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982069009
    PMA / PMN Number
    K040336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. A REVIEW OF THE DEVICE HISTORY RECORD DEVICE HISTORY LOT PART NUMBER: 03.010.482, LOT NUMBER: T993311, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: 27-JUL-2013. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY BACKGROUND: UPDATED EVENT DESCRIPTION (ADDITIONAL INFORMATION) IT WAS REPORTED THAT DURING A RECON NAIL SURGERY ON (B)(6) 2019, THE CANNULAS OF TWO (2) RADIOLUCENT RECON AIMING ARM FOR EXPERT LATERAL FEMORAL NAIL (LFN) WERE A LITTLE BIT LOOSE INSIDE. THE GUIDE WIRES FOUR (4) WAS MISSING THE RECON NAIL HOLE POSTERIOR AND ANTERIOR BY QUITE A BIT AND WAS UNABLE TO PROCEED WITH THE RECON NAIL LOCKING OPTION BECAUSE OF IT. EVEN AFTER LOCKING THE LARGEST GOLD CANNULA INTO THE RADIOLUCENT AIMING ARM, THE SURGEON AND THE SALES REP FELT AS THOUGH THERE WAS SOME "WIGGLE" ROOM OR A LITTLE BIT OF TOGGLE THAT COULD BE THE CAUSE OF THE GUIDEWIRES MISSING THE NAIL'S RECON HOLES. A FEW MILLIMETERS OF TOGGLE COULD CREATE A MISPLACED GUIDE WIRE THE SALES REP COMMENTED THAT THE INSTRUMENTS HAVE GOTTEN LOOSE OVER THE YEARS AS THEY HAVE BEEN USED. THERE WAS A SURGICAL DELAY OF 5-8 MINUTES. THE SURGERY WAS COMPLETED USING THE SAME AIMING ARMS AND THE STANDARD LOCKING OPTION FOR THE PATIENT. IT WAS AN IMPENDING FRACTURE DISTALLY DOWN THE SHAFT OF THE FEMUR, SO NOTHING WAS COMPROMISED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RECON NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES SIX (6) DEVICES. INVESTIGATION FLOW: FUNCTIONAL/DEVICE INTERACTION VISUAL INSPECTION: THE RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN (P/N 03.010.482 LOT T993311) WAS RECEIVED WITH NO VISUAL ISSUES/DEFECTS/DEFORMITIES OBSERVED. FUNCTIONAL INSPECTION FUNCTIONAL TESTING COULD NOT BE COMPLETED AS THE MATING GUIDE WIRES/OTHER MATING INSTRUMENTS WERE NOT RECEIVED FOR EVALUATION. THE CAM LOCKS WERE TESTED WITH GAGE PINS, ALONG WITH THE DIMENSIONAL INSPECTION (GP29), AND FULLY FUNCTIONAL. DIMENSIONAL INSPECTION: DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS UNCONFIRMED FOR THE RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN (P/N 03.010.482 LOT T993311) AS NO DEFECT OR DEFORMITIES WERE IDENTIFIED DURING THE INVESTIGATION THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DIMENSIONAL NON-CONFORMITIES WERE OBSERVED THAT MAY HAVE CAUSED ANY MATING DEVICES TO BE LOOSE. THE COMPLAINT CONDITION IS UNCONFIRMED. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    Description of Event or Problem · 0

    UPDATED EVENT DESCRIPTION (ADDITIONAL INFORMATION) IT WAS REPORTED THAT DURING A RECON NAIL SURGERY ON (B)(6) 2019, THE CANNULAS OF TWO (2) RADIOLUCENT RECON AIMING ARM FOR EXPERT LATERAL FEMORAL NAIL (LFN) WERE A LITTLE BIT LOOSE INSIDE. THE GUIDE WIRES FOUR (4) WAS MISSING THE RECON NAIL HOLE POSTERIOR AND ANTERIOR BY QUITE A BIT AND WAS UNABLE TO PROCEED WITH THE RECON NAIL LOCKING OPTION BECAUSE OF IT. EVEN AFTER LOCKING THE LARGEST GOLD CANNULA INTO THE RADIOLUCENT AIMING ARM, THE SURGEON AND THE SALES REP FELT AS THOUGH THERE WAS SOME "WIGGLE" ROOM OR A LITTLE BIT OF TOGGLE THAT COULD BE THE CAUSE OF THE GUIDEWIRES MISSING THE NAIL'S RECON HOLES. A FEW MILLIMETERS OF TOGGLE COULD CREATE A MISPLACED GUIDE WIRE THE SALES REP COMMENTED THAT THE INSTRUMENTS HAVE GOTTEN LOOSE OVER THE YEARS AS THEY HAVE BEEN USED. THERE WAS A SURGICAL DELAY OF 5-8 MINUTES. THE SURGERY WAS COMPLETED USING THE SAME AIMING ARMS AND THE STANDARD LOCKING OPTION FOR THE PATIENT. IT WAS AN IMPENDING FRACTURE DISTALLY DOWN THE SHAFT OF THE FEMUR, SO NOTHING WAS COMPROMISED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RECON NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES SIX (6) DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT DURING A RECON NAIL SURGERY ON (B)(6) 2019, THE CANNULAS OF TWO (2) RADIOLUCENT RECON AIMING ARM FOR EXPERT LATERAL FEMORAL NAIL (LFN) WERE A LITTLE BIT LOOSE INSIDE. THE FOUR (4) GUIDE WIRES MISSED THE RECON NAIL HOLE POSTERIOR AND ANTERIOR BY QUITE A BIT AND BECAUSE OF IT SURGEON WAS UNABLE TO PROCEED WITH THE RECON NAIL LOCKING OPTION. EVEN AFTER LOCKING THE LARGEST GOLD CANNULA INTO THE RADIOLUCENT AIMING ARM, THE SURGEON AND THE SALES REP FELT AS THOUGH THERE WAS SOME "WIGGLE" ROOM OR A LITTLE BIT OF TOGGLE THAT COULD BE THE CAUSE OF THE GUIDEWIRES MISSING THE NAIL'S RECON HOLES. A FEW MILLIMETERS OF TOGGLE COULD CREATE A MISPLACED GUIDE WIRE. THERE WAS A SURGICAL DELAY OF 5-8 MINUTES. THE SURGERY WAS COMPLETED USING THE SAME AIMING ARMS AND THE STANDARD LOCKING OPTION FOR THE PATIENT. IT WAS AN IMPENDING FRACTURE DISTALLY DOWN THE SHAFT OF THE FEMUR, SO NOTHING WAS COMPROMISED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RECON NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) RADIOLUCENT RECON AIMING ARM. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738833 RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.482 T993311 10886982069009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - NAILS