BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT INSERTER

    MDR report key: 8905660 · Received August 19, 2019

    Report

    Report Number
    2939274-2019-59875
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 22, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034731681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. H3, H4, H6: PART: 03.820.129, LOT: T921171: MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: APRIL 21, 2008. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. REVIEW OF RAW MATERIAL CERTIFICATE COULD NOT BE ESTABLISHED DURING THIS REVIEW DUE TO THE AGE OF THE DEVICE (OVER 11 YEARS OLD). H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: THE INSTRUMENT WAS NOT RETURNED, AND THE INVESTIGATION WAS COMPLETED BASED ON THE SUPPLIED IMAGE. THE IMAGE WAS REVIEWED, AND THE COMPLAINT CONDITION COULD NOT BE CONFIRMED. THE SUPERIOR SURFACE OF THE IMPLANT INSERTER SHOWS VISIBLE SIGNS OF WEAR CONSISTENT WITH NORMAL USE. AS THE INSTRUMENT WAS NOT RETURNED AND RECEIVED, DIMENSIONAL, MATERIAL OR DRAWING REVIEWS COULD NOT BE COMPLETED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. HOWEVER, THE DEVICE IS LIKELY WORN FROM REPEATED USE AND SERVICING FROM OVER 11 YEARS OF USE. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 DURING INSERTION OF A PRODISC-C (PDC) IMPLANT ON 1ST LEVEL (C4-C5) ON (B)(6) 2019, THE TONG THAT CAPTURES THE IMPLANT BROKE OFF. THE IMPLANT WAS AT THE FINAL POSITION. THE SMALL BROKEN PIECE WAS CAPTURED AND REMOVED. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: PRODISC C IMPLANT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700358 IMPLANT INSERTER MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.820.129 T921171 10705034731681

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - ARTIFICIAL DISC REPLACEMENT: PRODISC C