BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIVATE REVERSE SHOULDER INSTRUMENT

    MDR report key: 11782864 · Received May 6, 2021

    Report

    Report Number
    1644408-2021-00383
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 12, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ENCORE MEDICAL L. P.
    Product Code
    KWS
    UDI-DI
    00190446269106
    PMA / PMN Number
    K172351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THIS COMPLAINT WAS A INSTRUMENT FAILURE REPORTED AS SOME THREADS WERE STILL IN THE IMPLANT STEM AFTER REMOVAL. THE POSSIBLE TIME IN SERVICE OF THE MAIN CONTRIBUTOR OF THE COMPLAINT IS 3 YEARS AND 1 MONTH FROM THE MANUFACTURER DATE. THE HEALTHCARE PROFESSIONAL INDICATED THAT THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT AND THERE WAS A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THE SURGERY WAS COMPLETED AS INTENDED, WITH DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. THE AGENT WAS PRESENT DURING SURGERY AND WAS ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. THE DEVICE WAS RETURNED TO MANUFACTURER AND MADE AVAILABLE AT DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORD (DHR) REVEALED THE INSTRUMENT, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS NO NON-CONFORMING MATERIAL REPORT (NCMR) ASSOCIATED WITH THE PRODUCTION OF THE INSTRUMENTS THAT ARE RELATED TO THE REPORTED ISSUE. COMPLAINT DATABASE REVIEW SHOWS NO PRIOR COMPLAINTS FILED AGAINST THE INSTRUMENTS' ITEM NUMBER OR LOT NUMBER THAT REPORTS A SIMILAR FAILURE. NO PRIOR COMPLAINTS REPORT PAST INSTANCES OF THESE INSTRUMENTS BEING AFFECTED BY THIS FAILURE. THE ROOT CAUSE OF THIS COMPLAINT WAS LIKELY ATTRIBUTABLE TO DAMAGE INCURRED FROM PROLONGED USE AND THROUGH MISUSE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION OR ISSUE. THERE ARE NO INDICATIONS THAT THIS INSTRUMENT HAS A SYSTEMIC DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. RMA EXAMINATION: THE REPORTED INSTRUMENT WAS RETURNED TO DJO AND AFTER FURTHER EXAMINATION, THE THREADS OF THE ALTIVATE REVERSE, SMALL HUMERAL STEM IMPLANT INSERTER KNOB ARE DAMAGED, CONFIRMING THE COMPLAINT. THE REPORTED CONDITION OF THE ABOVE INSTRUMENTS COULD POSSIBLY BE A RESULT OF REPEATED USE, MISUSE, WEAR AND CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR PERFORMANCE. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - DUE TO WHEN DISENGAGING THE STEM INSERTER FROM THE STEM, UPON REMOVAL, WE NOTICED SOME THREADS WERE STILL IN THE IMPLANT STEM. CASE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT OR TIMING. BROKEN INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684233 ALTIVATE REVERSE SHOULDER INSTRUMENT ALTIVATE REVERSE, SMALL HUMERAL STEM IMPLANT INSERTER KNOB KWS ENCORE MEDICAL L. P. 804-06-157 266605L04 00190446269106

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other