MAUDE Adverse Event Report: ARTHREX, INC. PROBE, HOOK 3.4MM TIP W/5MM MARKINGS; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported during the shoulder arthroscopy that the tip of the instrument had broken off.The broken pieces were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-10010, probe, hook 3.4mm tip w/5mm markings, with batch 66498 was received for investigation and upon visual inspection, it was noted that the distal tip is broken off (see evaluation picture 3).No fragments were returned for inspection.Further the handle is discolored (see evaluation picture 1).Functional test was not performed due to the damage to the device.This is most likely caused by applying excessive leveraging forces.

• Brand Name: PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
• 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: 23714752
• Report Number: 1220246-2025-05386
• Device Sequence Number: 18712929
• Product Code: LXH
• UDI-Device Identifier: 00888867002364
• UDI-Public: (01)00888867002364(10)66498
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
• Device Catalogue Number: AR-10010
• Device Lot Number: 66498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown