MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; HEXDRIVER, STRAIGHT MOD

Catalog Number	803-05-167
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The agent reported, "glenoid base plate driver snapped off in the base plate".This event occurred during the surgery near the patient.The surgeon reported, "broken tip left in baseplate could not get out." there was a delay in surgery, but the time was not recorded.The surgery was completed as intended.The agent was present when this event occurred and was able to provide another suitable device.The instrument was inspected prior to use and found acceptable.Rma examination: the reported device was returned to surgical, and examination confirmed that the hex driver had broken off.A review of the instrument's device history records (dhr) revealed that, when released for use, it met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.Customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.Based on the information available, there are no indications that the instrument has a design or material deficiency.Therefore, no containment of inventory is required.The event is associated with instrument usage, not a design or manufacturing issue.The root cause of this complaint was that the glenoid baseplate driver fractured during use, causing the tip to break off and remain lodged inside the baseplate (in the patient).
Event or Problem Description
Instrument failure - glenoid baseplate driver snapped off in the baseplate, delat in surgery, broken fragmnented pieces left in the patiet.

• Brand Name: DJO SURGICAL
• Common Device Name: HEXDRIVER, STRAIGHT MOD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 24596604
• Report Number: 1644408-2026-00267
• Device Sequence Number: 8355402
• Product Code: LXH
• UDI-Device Identifier: 00190446284376
• UDI-Public: 00190446284376
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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): 03/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 803-05-167
• Device Lot Number: 445697L01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male