MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; ALTIVATE REVERSE GLENOID BASEPLATE INSERTER, WEDGE

Model Number	804-06-324
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon was utilzing the glenoid wedge baseplate inserter (804-06-324) to implant the glenoid wedge baseplate.After implant was implanted, the inserter was removed and handed back to the scrub tech.The scrub tech showed me the inserter and we noticed that the peg was missing from the guide.The surgeon was notified immediately and he determined that the peg had snapped off in the patient.He made 4 attempts to remove with a hemostat but was unsuccessful.The surgeon decided to leave the broken peg in the patient and continued to complete the surgery.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number cc-00528466_1644408-2026-00211; cc-00528466, 804-06-324, s303 - broke/cracked/damaged, instrument failure.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOID BASEPLATE INSERTER, WEDGE
• 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: 24631468
• Report Number: 1644408-2026-00492
• Device Sequence Number: 9173961
• Product Code: KWS
• UDI-Device Identifier: 00190446844150
• UDI-Public: 00190446844150
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K233481
• 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): 03/18/2026

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: 804-06-324
• Device Lot Number: 446345L02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female