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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the jaw in the front is broken off.The problem was noticed during reprocessing.No further information received.(b)(6) 2022 update: further information were provided that the reported event occurred during a surgery.The parts did not remain in the patient.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection it was found that the upper jaw is missing and a piece of the actuator was broken off near the attachment to the jaw.The broken fragments were not returned for evaluation.The cause remains undetermined, although a probable cause is attributed to the application of leveraging forces on the distal end of the device.Upon functional testing it was found that the actuator still functions.

• 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: 14336103
• Report Number: 1220246-2022-04856
• Device Sequence Number: 5219390
• Product Code: MDM
• UDI-Device Identifier: 00888867032743
• UDI-Public: 00888867032743
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/25/2022

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: 87130
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown