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

Catalog 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	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - during surgery, the blue post on the altivate reverse glenoid baseplate inserter wedge # 804-06-324 broke off in the patient during implantation of the wedge baseplate.This caused a 10 minute delay while we determined how to beat remove from our drill hole in order to proceed.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See h6, and h11 for additional information.The agent reported "during surgery, the blue post on the altivate reverse glenoid baseplate inserter wedge #804-06-324 broke off in the patient during implantation of the wedge baseplate.This caused a 10 minute delay while we determined how to beat remove from our drill hole in order to proceed male." this event occurred during surgery near the patient.Healthcare professional indicated significant adverse event.A 10 min.Delay in surgery was noted.When this event occurred, there was another suitable device available, and the surgery was completed as intended.The device was inspected prior to use and found acceptable.Rma examination: the reported device was not returned to surgical for evaluation.If at a later time the device is returned, an amendment will be opened to evaluate the event.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.A review of the instrument's device history records (dhr) could not be conducted since the lot number was not provided and the item was not returned for evaluation.The root cause of this complaint was the post of the inserter broke off, likely due to prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is an event associated with usage, not an event associated with product failure, malfunction, or issue.Customer complaint history of the reported device(s) showed no present trends or on-going issues that need a review.There are no indications that the instrument has a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOID BASEPLATE INSERTER, WEDGE
• 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: 22040665
• Report Number: 1644408-2025-00588
• Device Sequence Number: 9095774
• Product Code: KWS
• UDI-Device Identifier: 00190446844150
• UDI-Public: 00190446844150
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 804-06-324
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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 Sex: Male