MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE

Catalog Number	804-06-310
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Instrument failure - when the doctor went to use the reamer, the reamer would get bound up before he even was able to place it in the patient.We opened up another set tried with the other one and it did the same thing.
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 d4, h4, h6, h10, and h11.Complaint has been evaluated and is similar to report number 1644408-2025-00204; 804-06-310, s100 - functional, instrument failure; surgical - quality complaints.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 WEDGE GLENOID REAMER SLEEVE
• 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: 21704301
• Report Number: 1644408-2025-00406
• Device Sequence Number: 10130991
• Product Code: KWS
• UDI-Device Identifier: 00190446843818
• UDI-Public: 00190446843818
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/15/2025

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: 804-06-310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 804-06-311 LOT: UNKNOWN.; 804-06-311 LOT: UNKNOWN.; 804-06-311 LOT: UNKNOWN.; 804-06-311 LOT: UNKNOWN.; 804-06-312 LOT: UNKNOWN.; 804-06-312 LOT: UNKNOWN.; 804-06-312 LOT: UNKNOWN.; 804-06-312 LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female