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

Model Number	MEGABITER, UP CURVED TIP, 5.5MM X 2.5MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery a part of the device broke inside the patient.All fragments were retrieved from the patient.No harm for patient, operator or third party was reported.No further information received.
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 confirmed.One unpackaged ar-41026 was received for investigation.Visual inspection identified that the 723-4002 cutter had broken off.Wear was noted to the cutter fragment.A probable cause is attributed to wear and tear damage based on the age of the device.

• Brand Name: MEGABITER, UP CURVED TIP, 5.5MM X 2.5MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 13528661
• Report Number: 1220246-2022-04468
• Device Sequence Number: 11915280
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 87030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown