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	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/25/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-41006 megabiter tip was broken.The case was completed using another ar-41006 megabiter.All fragments were retrieved.No patient effect.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-41006 megabiter lot number: 15030320 was received for investigation.Visual evaluation noted that the cutter of the device was broken off and missing.Functional testing was unable to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• 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: 19388581
• Report Number: 1220246-2024-03807
• Device Sequence Number: 12501534
• Product Code: MDM
• UDI-Device Identifier: 00888867196339
• UDI-Public: 00888867196339
• 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): 09/16/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 09/16/2024
• 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