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	11/05/2024
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 that during a shoulder arthroscopy the device was very thin at the front and therefore got bent during the procedure.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same devices.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, ar-10010, probe - hook, batch 15155189, was received for investigation.Visual evaluation noted that that the probe hook was bent.Functional testing was not performed as it is irrelevant to the complaint allegation.The most likely cause for the reported failure can be attributed to misaligned insertion; excessive force while prying/leveraging the device during insertion.

• 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: 20855071
• Report Number: 1220246-2024-08717
• Device Sequence Number: 8839376
• Product Code: LXH
• UDI-Device Identifier: 00888867002364
• UDI-Public: (01)00888867002364(11)231017(10)15155189
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 15155189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown