MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE ANATOMIC AG, HALF WEDGE REAMING GUIDE, 5MM, RIGHT

Catalog Number	804-09-027
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - cold welded the short pins into all 4 guides, 30 minute delay in surgery.
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
Complaint, cold welded the short pins into all 4 guides, 30min delay in surgery.
Additional Manufacturer Narrative
Device history: 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.Root cause: the root cause of this complaint was the cold welding the short pins into all 4 guides, likely due to repeated use and time in service.Refer to the instrument ifu for the correct use and care of the instrument.This is an event associated with use, not an event associated with product failure, malfunction, or issue.Complaint history: complaint database review showed previous complaints but there were no indications that these instruments have a design or material deficiency.Containment: there are no indications that these instruments have 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 ANATOMIC AG, HALF WEDGE REAMING GUIDE, 5MM, RIGHT
• 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: 23986233
• Report Number: 1644408-2026-00115
• Device Sequence Number: 4630169
• Product Code: PAO
• UDI-Device Identifier: 00190446729105
• UDI-Public: 00190446729105
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K213387
• 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): 01/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 804-09-027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/06/2026
• 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: Unknown