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

Model Number	MEGABITER, UP CURVED 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	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a meniscal resection surgery the tip of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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
The complaint is confirmed.One unpackaged ar-41026 serial/batch number 14930125 was received for investigation.No functional testing for this device with the broken cutter.Upon visual evaluation, it was noted that the cutter was detached from the actuator.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.Per (b)(4).Cautions.6.Flexion of the joint with the instrument in position in the joint may result in bending or breakage of the instrument.

• Brand Name: MEGABITER, UP CURVED 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: vik bajnath ; 8009337001
• MDR Report Key: 17086013
• Report Number: 1220246-2023-06868
• Device Sequence Number: 14974404
• Product Code: MDM
• UDI-Device Identifier: 00888867032743
• UDI-Public: 00888867032743
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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, UP CURVED TIP, 5.5MM X 2.5MM
• Device Catalogue Number: AR-41026
• Device Lot Number: 14930125
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown