BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 12235735 · Received July 27, 2021

    Report

    Report Number
    8030965-2021-06129
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    July 10, 2021
    Report Date
    July 13, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. H10 ADDITIONAL NARRATIVE: D4: LOT, CATALOG AND UDI D9 G1: MANUFACTURING SITE NAME AND ADDRESS G4 H3, H4, H6: PART # 03.010.405 LOT # L181369 MANUFACTURING SITE: WERK HAGENDORF RELEASE TO WAREHOUSE DATE: JANUARY 4, 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE INSERT-HANDLE RADIOLUC F/PFNA (PART# 03.010.405, LOT# L181369 QTY# 1) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, NO ISSUES WERE FOUND WITH THE DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE MATING DEVICES WERE NOT RETURNED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? UNABLE TO PERFORM. DIMENSIONAL INSPECTION: DRAWING: ZIELBUEGEL PFNA-LL EU: MANUFACTURED REVISION. INTERNAL DIAMETER (B): RESULT, CONFORMING CALIPER. EXTERNAL DIAMETER (B): RESULT, CONFORMING CALIPER. DRAWING: PFNA ZIELBUEGEL KPL: MANUFACTURED REVISION. INTERNAL DIAMETER (E): RESULT, CONFORMING GAGE PINS. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED: -PFNA ZIELBUEGEL KPL: CURRENT AND MANUFACTURED REVISIONS -ZIELBUEGEL PFNA-LL EU: CURRENT AND MANUFACTURED REVISIONS NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THE COMPLAINT CANNOT BE CONFIRMED FOR THE INSERT-HANDLE RADIOLUC F/PFNA (PART# 03.010.405, LOT# L181369 QTY# 1) AS A FUNCTIONAL TEST COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM. 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 UPON THESE RESULTS, 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 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. D1.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN GUIDES/SLEEVES/AIMING: AIMING ARM/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) PROCEDURE, ONE (1) UNKNOWN PFNA NAIL, ONE (1) UNKNOWN DISTAL LOCKING NAIL, AND ONE (1) UNKNOWN AIMING ARM DID NOT OPERATE CORRECTLY. THE UNKNOWN DISTAL LOCKING NAIL MOVED AROUND THE NAIL AND THE AIMING ARM CAUSED DIFFICULTY PLACING THE DISTAL LOCKING NAIL. THERE WAS A SURGICAL DELAY OF FIFTY (50) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - NAIL HEAD ELEMENTS: PFNA BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY# 1). THIS REPORT IS FOR ONE (1) UNK - GUIDES/SLEEVES/AIMING: AIMING ARM. THIS IS REPORT 2 OF 3 FOR (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132157 RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS MISC ORTHO SURGICAL INSTR LXH SYNTHES GMBH L181369

    Patients

    Seq Age Sex Outcome Treatment
    1