BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPS

    MDR report key: 9835086 · Received March 16, 2020

    Report

    Report Number
    2939274-2020-01289
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 18, 2020
    Report Date
    February 18, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWN
    UDI-DI
    10886982076267
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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. THE COMPRESSION FORCEPS (P/N: 03.211.400, LOT #: T950761) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE SMALL LEAF SPRING COMPONENT WAS OBSERVED TO BE BROKEN NEAR THE M2. 5 X 6 SCREW COMPONENT. THERE WAS SLIGHT DISCOLORATION OBSERVED ON THE RETURNED DEVICE BUT HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. THE COMPLAINT CONDITION IS CONFIRMED FOR THE COMPRESSION FORCEPS (P/N: 03.211.400, LOT #: T950761). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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. DEVICE HISTORY LOT PART NUMBER: 03.211.400, LOT NUMBER: T950761, MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: 16-NOV-2010. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. 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 WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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) 2020 DURING A LISFRANC PROCEDURE THAT IT WAS DISCOVERED THAT THERE WERE TWO BROKEN INSTRUMENTS. ONE (1) FROM A LOCKING COMPRESSION PLATE (LCP) MINI FRAGMENT SET AND THE OTHER (1) FROM A VARIABLE (VA) FOREFOOT/ MIDFOOT SET. THERE WERE NO FRAGMENTS GENERATED FORM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE COMPRESSION FORCEPS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299389 COMPRESSION FORCEPS INSTRUMENT COMPRESSION HWN WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.211.400 T950761 10886982076267

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR