BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 24864583 · Received April 13, 2026

    Report

    Report Number
    1644408-2026-00659
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    HXX
    UDI-DI
    00190446844198
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION: THE AGENT REPORTED, "THE SURGEON HAD THE T20 TORX DRIVER ON POWER AND WAS USING THAT TO SCREW THE SCREW INTO THE BASEPLATE. WHEN THE SURGEON DID THAT, THE TIP OF THE TORX DRIVER SHEARED OFF INTO THE SCREW." ITEM NUMBER: 804-06-332 ITEM DESCRIPTION: EMPOWR ACETABULAR, BONE SCREW, 35MM LOT#: UNKNOWN PART REVISION:NA PRODUCT TYPE: SHOULDER MANUFACTURE DATE: UNKNOWN POSSIBLE TIME IN SERVICE: UNKNOWN. THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RESPONSE WAS RECEIVED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED, WITH A TEN-MINUTE DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND DEEMED ACCEPTABLE BASED ON ITS APPEARANCE. THE AGENT WAS PRESENT DURING SURGERY, AND HE WAS ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. RMA EXAMINATION: THE REPORTED INSTRUMENT WAS NOT RETURNED TO ENOVIS SURGICAL FOR EVALUATION. NO FURTHER EVALUATION CAN BE MADE FOR THIS EVENT. THIS CUSTOMER COMPLAINT WILL BE CLOSED. IF THE DEVICE IS RETURNED LATER, THE COMPLAINT WILL BE UPDATED. ROOT CAUSE: THE ROOT CAUSE OF THIS COMPLAINT IS THAT THE T20 TORX DRIVER TIP WAS SHEARED OFF DURING ENGAGEMENT OF THE SCREW INTO THE BASEPLATE. ALTHOUGH UNCOMMON, THE DRIVER TIP CAN SHEAR WHEN SUBJECTED TO TORSIONAL FORCES EXCEEDING NORMAL OPERATING CONDITIONS DURING POWERED SCREW INSERTION, PARTICULARLY WHEN ENCOUNTERING INCREASED RESISTANCE. THIS REPRESENTS A TRANSIENT MECHANICAL OVERLOAD RATHER THAN AN INHERENT PRODUCT FAILURE, MALFUNCTION, OR ISSUE. CONTAINMENT: THERE ARE NO INDICATIONS THAT THE INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO INVENTORY CONTAINMENT IS REQUIRED. THE EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. DEVICE HISTORY RECORDS REVIEW: THE REVISION LEVEL OR LOT NUMBER WERE NOT REPORTED; THEREFORE, THIS INSTRUMENT COULD NOT BE LINKED TO A SPECIFIC DEVICE HISTORY RECORD (DHR) OR THE ACTUAL DATE OF MANUFACTURE COULD NOT BE DETERMINED WITH CONFIDENCE. COMPLAINT HISTORY: THE CUSTOMER COMPLAINT HISTORY FOR THE REPORTED DEVICE(S) SHOWED NO CURRENT TRENDS OR ONGOING ISSUES THAT REQUIRE REVIEW.

    Description of Event or Problem · 0

    THE SURGEON HAD THE T20 TORX DRIVER ON POWER AND WAS USING THAT TO SCREW THE SCREW INTO THE BASEPLATE. WHEN THE SURGEON DID THAT, THE TIP OF THE TORX DRIVER SHEARED OFF INTO THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918122 DJO SURGICAL ALTIVATE REVERSE GLENOID PERIPHERAL SCREW T20 DRIVER HXX ENCORE MEDICAL LP 804-06-332 00190446844198

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other