BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNMESH® IMPLANT HOLDER LARGE/WITH TIPS

    MDR report key: 8957038 · Received September 3, 2019

    Report

    Report Number
    2939274-2019-60281
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Report Date
    August 6, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034777467
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. H10 ADDITIONAL NARRATIVE: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: VISUAL INSPECTION WAS PERFORMED ON RECEIVED DEVICE (PART# 396.389, LOT# A7OA08, MFG#WEEK 08, 2005) SHOWED THAT INNER SPRING HAS BEEN BROKEN. THE RECEIVED CONDITION OF THE DEVICE MATCHES WITH THE COMPLAINT CONDITION. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWING(S) WAS REVIEWED. THE DEVICE IS BROKEN. HENCE CONFIRMING THE ALLEGATION. CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 396.389 LOT NUMBER: A7OA08 MANUFACTURING SITE: TUTTLINGEN RELEASE TO WAREHOUSE DATE: WEEK 08, 2005 A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE, THE DHR IS NO LONGER AVAILABLE DUE TO THE AGE OF THE INSTRUMENT (OVER 14 YEARS OLD). 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 RETURNED. THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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

    LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SYNMESH IMPLANT HOLDER WAS FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748799 SYNMESH® IMPLANT HOLDER LARGE/WITH TIPS MISC., ORTHO, SURGICAL, INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 396.389 A7OA08 10705034777467

    Patients

    Seq Age Sex Outcome Treatment
    1