MAUDE Adverse Event Report: ARTHREX, INC. MEGABITER, STRAIGHT TIP, 5.5MM X 2.5MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	MEGABITER, STRAIGHT TIP, 5.5MM X 2.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
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
On 01/10/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-41006 megabiters clamp broke.This occurred during a case when the clamp broke inside the joint.There was no additional information provided, and additional information has been requested.
Event or Problem Description
Additional information was provided where the arthrex subsidiary employee stated this event occurred on (b)(6) 2025, where no fragments were left in the patient.The technique was used correctly.The broken clamp was replaced with a home-made one and the surgery was completed successfully.There was no delay or addition of anesthesia.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint device was not received for evaluation.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 concluded that the most likely cause of the reported failure can be attributed to user error due to misalignment insertion, and/or prying/leveraging of the device.The complaint allegation was confirmed based on the customer's attached picture, which shows the instrument displayed with the tip broken and bent.

• Brand Name: MEGABITER, STRAIGHT TIP, 5.5MM X 2.5MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 21304093
• Report Number: 1220246-2025-00154
• Device Sequence Number: 18147658
• Product Code: MDM
• UDI-Device Identifier: 00888867196339
• UDI-Public: (01)00888867196339(11)220222(10)14930873
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/04/2025

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: MEGABITER, STRAIGHT TIP, 5.5MM X 2.5MM
• Device Catalogue Number: AR-41006
• Device Lot Number: 14930873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2022
• 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