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

Model Number	804-06-324
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation: the agent reported, "the peg on blue arg inserter broke while impacting and stayed in patient.Attempts were made to get it out, but ultimately it was unable to be retrieved without causing subsequent damage." item number: 804-06-324.Item description: activate reverse glenoid baseplate inserter, wedge.Part revision: na.Lot #: unknown.Product type: shoulder manufacture date: unknown.Possible time in service: unknown.This event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, and there was a thirty-minute 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.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 peg on the blue arg inserter fractured during impaction, resulting in the broken fragment remaining in the patient.The reported condition could possibly be a result of heavy use or misuse and care must be taken to avoid compromising their performance.Refer to the instrument ifu.Containment: 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.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: there is inadequate information to complete an assessment of the complaint history for the reported device.
Event or Problem Description
The peg on blue arg inserter broke while impacting and stayed in patient.Attempts were made to get it out, but ultimately it was unable to be retrieved without causing subsequent damage.
Event or Problem Description
The peg on blue arg inserter broke while impacting and stayed in patient.Attempts were made to get it out, but ultimately it was unable to be retrieved without causing subsequent damage.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number cc-00528466_1644408-2026-00211; 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: 24706156
• Report Number: 1644408-2026-00519
• Device Sequence Number: 21359577
• Product Code: KWS
• UDI-Device Identifier: 00190446844150
• UDI-Public: 00190446844150
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Followup
• Report Date (Section B): 03/26/2026

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: 410796L02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown