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	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The device was not returned for evaluation and therefore the alleged complaint event could not be confirmed.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.
Event or Problem Description
It was reported that during an arthroscopy the forceps broke off when the device was pulled out of the patient's knee joint.It was further reported that the forceps broke outside the joint and it was confirmed with an x-ray that nothing was left inside the patient.According to the surgeon there was no harm for patient, operator or third party reported.No further information received.17-nov-2022 update dw: further information were provided that the surgery could be finished successfully.

• 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: 19499145
• Report Number: 1220246-2024-05408
• Device Sequence Number: 20810294
• Product Code: MDM
• UDI-Device Identifier: 00888867196339
• UDI-Public: 00888867196339
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown