MAUDE Adverse Event Report: ARTHREX, INC. TRIM-IT CUSTOM HIP CANNULA; ORTHOPEDIC MANUAL SURG INSTR

Model Number	TRIM-IT CUSTOM HIP CANNULA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 12-jan-2026, it was reported by a sales representative via (b)(4) that an ar-6590 trim-it custom hip cannula broke.This was discovered during a hip arthroscopy procedure with no patient harm.It was reported that while inserting an instrument through the cannula, a plastic disc from the cannula dam was pushed into the joint.The fragment was retrieved with no adverse effects to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported issue is damage to the cannula dam, resulting from excessive force used during instrument insertion through the cannula, which dislodged the plastic disc.The available information does not indicate a confirmed manufacturing defect.

• Brand Name: TRIM-IT CUSTOM HIP CANNULA
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24239851
• Report Number: 1220246-2026-00360
• Device Sequence Number: 13004475
• Product Code: LXH
• UDI-Device Identifier: 00888867225879
• UDI-Public: (01)00888867225879(11)250801(17)300731(10)5211170983
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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 Model Number: TRIM-IT CUSTOM HIP CANNULA
• Device Catalogue Number: AR-6590
• Device Lot Number: 5211170983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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
• Patient Sex: Unknown