MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; ALTIVATE REVERSE GLENOID PERIPHERAL SCREW T20 DRIVER

Model Number	804-06-332
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOID PERIPHERAL SCREW T20 DRIVER
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758 ; 8003219549
• MDR Report Key: 24864583
• Report Number: 1644408-2026-00659
• Device Sequence Number: 13380985
• Product Code: HXX
• UDI-Device Identifier: 00190446844198
• UDI-Public: 00190446844198
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 804-06-332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female