BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS SLAP HAMMER

    MDR report key: 7483543 · Received May 3, 2018

    Report

    Report Number
    1220246-2018-00166
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    April 11, 2018
    Report Date
    May 3, 2018
    Manufacturer
    ARTHREX INC.
    Product Code
    LXH
    UDI-DI
    00888867058385
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS ONE OF TWO SUBMISSIONS FROM THE SAME EVENT. THE OTHER ONE IS (B)(4) LINE 231362-00165. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINT CONFIRMED. THE EVALUATION REVEALED THAT THE DEVICE'S BALL TIP WAS BROKEN-OFF. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. THE COMPLAINANT'S EVENT IS MOST LIKELY DUE TO LEVERAGING THE SLAP HAMMER DURING EXTRACTION THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A TOTAL SHOULDER ARTHROPLASTY PROCEDURE WHERE A UNIVERS II 10MM STEM (LOT: UNKNOWN, LINE: 231362) WAS IMPLANTED. 7 YEARS LATER, THE PATIENT OBTAINED AN INFECTION AT THE INCISION SITE AND UNDERWENT A TOTAL SHOULDER REMOVAL PROCEDURE. DURING THE REMOVAL, THE ATTACHMENT TIP OF THE SLAP HAMMER (LOT: 250150205, LINE 231389) BROKE OFF AFTER ONLY A COUPLE OF USES. THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED, HOWEVER, IT WAS NOT VISIBLE ON THE POST-OP X-RAY. THE SURGEON BELIEVES IT MAY HAVE BEEN REMOVED VIA SUCTION. FOLLOW-UP INVESTIGATION: ORIGINAL SURGERY WAS PERFORMED 7 YEARS AGO. THE DEVICE REMOVED WAS A UNIVERS II 10MM STEM (UNKNOWN LOT #). NOTHING REPLACED THE EXPLANTED STEM AS THE PATIENTS SHOULDER WAS INFECTED. THE PATIENT WAS EXPERIENCING PAIN, PUSS AND A SWOLLEN SHOULDER. THE SALES REP HAS CONFIRMED THAT THE ATTACHMENT BEING USED WITH THE SLAP HAMMER WAS CHECKED AND THE BALL SHAPED TIP THAT IS MISSING FROM THE SLAP HAMMER WAS NOT INSIDE THE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326501 UNIVERS SLAP HAMMER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX INC. 250150205 00888867058385

    Patients

    Seq Age Sex Outcome Treatment
    1 Other