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	11/27/2024
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
On 9th december 2024, it was reported by an arthrex employee via email that an ar-41006, megabiter¿, straight tip, 5.5 mm x 2.5 mm, was broken.This was detected during a partial resection of degenerative torn meniscus procedure on (b)(6) 2024.The cutter of ar-41006 was broken and all the fragments were retrieved from patient.Procedure was successfully completed with no patient harm and no secondary procedure needed, by using another new ar-41006 instead.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-41006, megabiter¿, straight tip, 5.5 mm x 2.5 mm, serial/batch number (b)(6), was received for investigation.Visual inspection noted the moving jaw of the device is completely broken off.Functional testing was not performed due to the damage to the device.The most likely cause is attributed to misuse due to excessive user-applied mechanical forces.Dfu-0255-eo revision 5 warns the following: "2.To avoid damaging the instruments, do not impact or subject any instruments to blunt force.3.Do not use arthrex instruments for any purpose other than their intended use.Manipulating soft tissue or bone with an instrument not intended for that use may result in damage to the instrument.4.Instruments with adjustable components must be handled with care.Overtightening or rough handling of the instrument may damage the locking mechanism.Mechanisms with internal polymer components may become weakened after repeated autoclaving.5.Do not use an instrument that is intended to be used with a specific implant on another implant.6.Flexion of the joint with the instrument in position in the joint may result in bending or breakage of the instrument.7.Do not overstress the device or use device to pry tissue".

• 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: 21078463
• Report Number: 1220246-2025-09202
• Device Sequence Number: 6728110
• Product Code: MDM
• UDI-Device Identifier: 00888867196339
• UDI-Public: (01)00888867196339(11)221205(10)15030320
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/28/2025

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: 15030320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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