BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 12057496 · Received June 24, 2021

    Report

    Report Number
    2939274-2021-03190
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 29, 2021
    Report Date
    May 29, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069351
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. IT WAS REPORTED THAT ON (B)(6), 2021, DURING AN UNKNOWN PROCEDURE, WHILE STRIKING THE FEMORAL RECON NAIL SYSTEM (FRN) NAIL WITH A MALLET THE DRIVING CAP BROKE OFF INTO THE RADIOLUCENT INSERTION HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONE MINUTE SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY. RADIOLUCENT INSERTION HANDLE FRN (PART# 03.033.001, LOT# L700507, QUANTITY 1); 10 / TI CANN FRN / PF 380 / RIGHT - SILE (PART# 04.033.038S, LOT# 5L93259, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE IMAGES LOCATED IN PC ATTACHMENTS ¿GITHENS DRIVING CAP (B)(4)" AND "GITHENS INSERTION HANDLE (B)(6) 2021 FRN CST.JPG". UPON INSPECTING THE IMAGES PROVIDED, THE TIP OF THE DRIVING CAP HAD BROKEN OFF AND BROKEN FRAGMENT COULD BE SEEN STUCK IN THE RADIOLUCENT HANDLE IN THE IMAGES. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHOTO/VIDEO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY LOT. PART: 03.010.523. LOT: L759640. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 17APRIL 2018. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2021, DURING AN UNKNOWN PROCEDURE, WHILE STRIKING THE FEMORAL RECON NAIL SYSTEM (FRN) NAIL WITH A MALLET THE DRIVING CAP BROKE OFF INTO THE RADIOLUCENT INSERTION HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONE MINUTE SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953272 DRIVING CAP/THREADED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L759640 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR 10 / TI CANN FRN / PF 380 / RIGHT - SILE| RADIOLUCENT INSERTION HANDLE FRN| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA