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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Primary surgery - the offset wedge reamer assembly locked up, the instruments were disassembled, cleaned and reassembled multiple time with the same outcome causing a 20 minute delay in surgery.
Additional Manufacturer Narrative
See d4 lot number, d10, h4 and h11.Evaluation: the agent reported "the offset wedge reamer assembly locked up, the instruments were disassembled, cleaned and reassembled multiple time with the same outcome male 71".This event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon and there here was a 20 min.Delay in surgery.The surgery was completed as intended even though there was not another suitable device.The instruments were inspected prior to use and found to be acceptable.Rma examination: an enovis corporate attendee noted that while grinding could be heard during evaluation, the construct spun freely prior to use.Reference: (b)(4) for more details.Device history: 804-06-310: a review of the receiver show that the reported component, when released for use, met design and manufacturing requirements.There was a ncmr-72640 which documents that out of 350 parts lot, 2 part were rejected due to discoloration on the diamond knurling post cleanroom processing.Later, the rejected part(s) were dispositioned as return to vendor (rtv).A review of the instrument's device history records (dhr) revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.804-06-311.A review of the instrument's device history records (dhr) and receiver revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.Complaint history: there are 21 other reported complaints for similar failure.S100 - functional.Root cause: the root cause of the complaints received for the wedge reamer constructs are due to the following: insufficient clearance between the reamer head cap (item 3, 804-06-311) and the reamer sleeve (item 1, 804-06-310).· user error of assembly, applying off axis force, insufficient clearing of the bone, and/or excessive pulling/pushing of reamer components.It was determined during the investigation that the root cause affects only 804-06-311, reamer head cap.There are no indications that 804-06-310, reamer sleeve and 804-06-312 reamer boss drill have any issues that would lead to the reported failure.

• 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: 21542796
• Report Number: 1644408-2025-00204
• Device Sequence Number: 20743893
• Product Code: KWS
• UDI-Device Identifier: 00190446843818
• UDI-Public: 00190446843818
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/25/2025

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: 414326L01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 804-06-311 LOT: 414326L02M.; 804-06-311 LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male