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	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the device does not function and the jaw could not be completely actuated/closed.The cause is undetermined.Nothing broke off from the device.
Event or Problem Description
On 02/07/2022, it was reported by a facility representative via sems that an ar-41026 megabiter is broken.This was discovered during use with no impact to the patient.Additional information requested.

• 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: 13620384
• Report Number: 1220246-2022-04514
• Device Sequence Number: 2096410
• Product Code: MDM
• UDI-Device Identifier: 00888867032743
• UDI-Public: 00888867032743
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

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: 11102053
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown