BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDLR CNLTD TRIDRV DRVR

    MDR report key: 17641445 · Received August 29, 2023

    Report

    Report Number
    1038671-2023-02074
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 7, 2023
    Report Date
    March 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    UDI-DI
    10885862085313
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE BROKEN CANNULATED TRI-DRIVER REPORTED WAS LIKELY THE RESULT OF THE RETAINING RING RESPONSIBLE FOR MAINTAINING ASSEMBLY OF THE SLEEVE ON THE TRI-DRIVER SHAFT BECOMING DEFORMED AS A RESULT OF THE SLEEVE BEING HELD STATIONARY WHILE REAMING OR THE SLEEVE BEING OBSTRUCTED BY SOFT TISSUE OR BONE. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 943, RING.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D8, E2, E3, G1. THE FOLLOWING SECTIONS WERE CORRECTED: D4: LOT NUMBER, G4: 510K, H6. THE BROKEN CANNULATED TRI-DRIVER REPORTED WAS LIKELY THE RESULT OF THE RETAINING RING RESPONSIBLE FOR MAINTAINING ASSEMBLY OF THE SLEEVE ON THE TRI-DRIVER SHAFT BECOMING DEFORMED AS A RESULT OF THE SLEEVE BEING HELD STATIONARY WHILE REAMING OR THE SLEEVE BEING OBSTRUCTED BY SOFT TISSUE OR BONE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G4:510K K042021, K093430 THE BROKEN CANNULATED TRI-DRIVER REPORTED WAS LIKELY THE RESULT OF THE RETAINING RING RESPONSIBLE FOR MAINTAINING ASSEMBLY OF THE SLEEVE ON THE TRI-DRIVER SHAFT BECOMING DEFORMED AS A RESULT OF THE SLEEVE BEING HELD STATIONARY WHILE REAMING OR THE SLEEVE BEING OBSTRUCTED BY SOFT TISSUE OR BONE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGICAL USE ON A MALE PATIENT, THE SURGEON WAS REAMING THE GLENOID, THE SPRING INSIDE THE TRI DRIVE HEAD SNAPPED, RESULTING IN IT NO LONGER BEING ABLE TO HOLD ONTO/CONNECT TO THE REAMER. THERE WAS NO EVIDENCE OF INAPPROPRIATE USE. THERE WAS A SPARE SO IT DID NOT IMPACT THE OPERATION. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. NO SURGICAL DELAY/PROLONGATION. UNABLE TO OBTAIN X-RAYS. DEVICE IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000317 MDLR CNLTD TRIDRV DRVR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH EXACTECH, INC. UNK 68107013 10885862085313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male UNK.