BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER WITH PISTOL GRIP

    MDR report key: 8451823 · Received March 26, 2019

    Report

    Report Number
    2939274-2019-57114
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    February 28, 2019
    Report Date
    February 28, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982076748
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. INVESTIGATION OF PHOTOGRAPH: NO ISSUES RELEVANT TO THE FUNCTIONAL COMPLAINT CONDITION WERE OBSERVED IN THE IMAGE PROVIDED. FADED ETCHING WAS NOTED; THE ETCHING WAS LEGIBLE. IT IS DETERMINED THAT THE REUSABLE INSTRUMENT DEVICE IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED DURING INVESTIGATION OF THE PHOTOGRAPH. A FADED ETCH WAS NOTED. AFTER A VISUAL INSPECTION, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT DEVICE IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. NO MANUFACTURING ISSUES WERE IDENTIFIED DURING INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES 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. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY LOT, PART NUMBER: 03.221.015, SYNTHES LOT NUMBER: P091331 , SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 13APR2011, EXPIRATION DATE: N/A, SUPPLIER: (B)(6). 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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON (B)(6) 2019 DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF DISTAL FEMUR/ PERIPROSTHETIC, THE CABLE TENSIONER WITH PISTOL GRIP WAS SLIPPING AND WOULD NOT TIGHTEN DURING FINAL TENSIONING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. SURGICAL DELAY IS UNKNOWN. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CABLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243864 CABLE TENSIONER WITH PISTOL GRIP MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.221.015 P091331 10886982076748

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR