BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0/8.0 PROTECTION SLEEVE 188 FOR ASLS

    MDR report key: 12215084 · Received July 22, 2021

    Report

    Report Number
    2939274-2021-04241
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Report Date
    June 25, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    10886982069900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. VISUAL INSPECTION: THE 11.0/8.0 PROTECTION SLEEVE 188 FOR ASLS (PART #: 03.025.040, LOT #: L182217) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED SURFACE SCRATCHES. NO OTHER DEFECT WAS OBSERVED. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED BY ASSEMBLING THE DEVICE WITH MATING DEVICE (PART # 03.010.065 LOT# L393577). BOTH ASSEMBLED CORRECTLY AND WERE INSERTED INTO THE ASSEMBLED AIMING ARM AND INSERTION HANDLE. NO ISSUE WAS IDENTIFIED AND THE 4 DEVICES ASSEMBLED CORRECTLY WITH NO ISSUE. THE MISALIGNMENT OF THE DEVICES COULD NOT BE CONFIRMED SINCE THE NAIL (IMPLANT) WAS NOT RETURNED. DOCUMENT/SPECIFICATION REVIEW: SE_033964 REV H (CURRENT) AND REV F (MANUFACTURED) WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS THERE WAS NO DEFECT OBSERVED ON THE RETURNED COMPLAINT DEVICE THAT COULD IMPACT THE ALIGNMENT WITH MATING DEVICES. HOWEVER SCRATCHES OBSERVED HAD NO IMPACT ON THE ALIGNMENT. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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 - A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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 ON UNKNOWN DATE, PATIENT WILL UNDERGO A TFNA PROCEDURE. DURING STERILE PROCESSING, WHILE CHECKING PROTECTION SLEEVE FOR SHORT TFNA BEFORE INSERTING TFNA NAIL AND IT WAS MISALIGNED. NO PATIENT CONSEQUENCES NOTED. THE PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (4) DEVICES. THIS REPORT IS FOR (1) 1.0/8.0 PROTECTION SLEEVE 188 FOR ASLS. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105758 11.0/8.0 PROTECTION SLEEVE 188 FOR ASLS MISC ORTHO SURGICAL INSTR LXH SYNTHES GMBH 03.025.040 L182217 10886982069900

    Patients

    Seq Age Sex Outcome Treatment
    1 130 DEG AIMING ARM| COMPLETE RADIOLUCENT INSERTION HANDLE| DRILLSL 8/4.2 F/03.010.063