BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T7 DRIVER CANN AO

    MDR report key: 5794765 · Received July 14, 2016

    Report

    Report Number
    0001825034-2016-02579
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    June 15, 2016
    Report Date
    March 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PK142658
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. PRODUCT REQUESTED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED CONDITION, AS THE DEVICE IS DEFORMED AND FRACTURED AT THE TIP. HOWEVER THE DRIVER TIP TWISTING IS INTENTIONALLY DESIGNED IN ORDER TO PREVENT THE SCREW HEAD FROM FRACTURING OR STRIPPING OUT. THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO TOO MUCH TORQUE APPLIED THAN THE DRIVER WAS DESIGNED TO WITHSTAND AND THE DRIVER TIP TWISTED TO PREVENT DAMAGE TO THE SCREW AND ULTIMATELY FRACTURED. HOWEVER, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: EVENT DATE: (B)(6) 2016 AND (510K #): K142658.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. ROOT CAUSE WAS DETERMINED TO BE DESIGN RELATED. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    DURING A FIRST METATARSOPHALANGEAL FUSION AND PROXIMAL PHALANX OSTEOTOMY, THE CANNULATED DRIVER FRACTURED OFF IN THE HEAD OF THE SCREW. THE FRACTURED PIECE WAS REMOVED FROM THE HEAD OF THE SCREW WITHOUT PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A SOLID DRIVER WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447642 T7 DRIVER CANN AO ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 14042A

    Patients

    Seq Age Sex Outcome Treatment
    1