BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 12228040 · Received July 27, 2021

    Report

    Report Number
    8030965-2021-06095
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 25, 2021
    Report Date
    June 29, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819096653
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. H3, H4, H6: PART: 359.219, LOT: 9443878, MANUFACTURING SITE: HAGENDORF, RELEASE TO WAREHOUSE DATE: 25 JUNE 2015. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE INSERTER F/TEN (PN: 359.219, LN: 9443878) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE DETERMINED THE BLUE HANDLE WAS BROKEN AT THE PROXIMAL END AND HAS MULTIPLE NICKS/GOUGES. HAMMER MARKS CAN BE SEEN ALL OVER THE BODY OF THE DEVICE INDICATING SIGNS OF HEAVY USE. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE. THE COUPLER/CHUCK WAS ABLE TO CLOSE ALL THE WAY AND THE KNOB WAS ROTATING FREELY. THE INSERTER FUNCTIONED AS INTENDED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? NO. THE COMPLAINT WAS NOT ABLE TO BE REPLICATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE FUNCTIONED AS INTENDED AND THE COMPLAINT CONDITION COULD NOT BE REPLICATED. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED: - EINSCHLAEGER KPL (CURRENT)/(MANUFACTURED) NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THIS COMPLAINT COULD NOT BE CONFIRMED FOR THE INSERTER F/TEN (PN: 359.219, LN: 9443878) AS THE DEVICE FUNCTIONED AS INTENDED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 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 WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY LOT: (B)(4), JULY 12, 2021: PART NUMBER: 359.219. LOT NUMBER: 9443878. 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, THE INSERTER FOR THE TITANIUM ELASTIC NAILS FAILED DURING A PROCEDURE. THE INSERTER WAS NOT GRIPPING THE NAIL SUFFICIENTLY TO ALLOW INSERTION. THEY WERE ABLE TO OPEN A SECOND SET TO COMPLETE THE PROCEDURE. THERE WAS A SHORT DELAY DURING THE PROCEDURE BUT NO CHANGE TO THE SURGICAL OUTCOME. THIS REPORT IS FOR ONE (1) INSERTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128540 INSERTER FOR TI ELASTIC NAILS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 9443878 07611819096653

    Patients

    Seq Age Sex Outcome Treatment
    1