BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE KIT 2.8MM SHOULDER Q-FIX

    MDR report key: 11800990 · Received May 10, 2021

    Report

    Report Number
    3006524618-2021-00593
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    LXH
    UDI-DI
    00885556724651
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION OF THE RETURNED INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. THE DRILL IS STUCK INSIDE THE DRILL GUIDE. A FUNCTIONAL EVALUATION THE DRILL IS LODGED INSIDE THE DRILL GUIDE AND CANNOT BE REMOVED. A REVIEW OF THE CUSTOMER PROVIDED IMAGE SHOWS TWO PRODUCT PACKAGING WITH THE SAME PRODUCT NUMBER 25-2810 AND LOT NUMBER 2062610. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. THE COMPLAINT WAS CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) EXCESSIVE FORCE (2) IMPROPER ALIGNMENT OF THE HANDLE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLAP REPAIR, THE Q-FIX WENT TO DRILL THE PILOT HOLE AND THE DRILL WENT INTO THE GUIDE AND GOT STUCK IN THE SHAFT OF THE GUIDE, IT WAS REMOVE IT SAFELY OUT OF THE SHOULDER, BUT IT BROKE WHEN TRIED TO DISLODGE THE DRILL/GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698760 DISPOSABLE KIT 2.8MM SHOULDER Q-FIX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROCARE CORP. 2062610 00885556724651

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention