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

Model Number	MEGABITER, STRAIGHT TIP, 5.5MM X 2.5MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2021
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 during a knee arthroscopy procedure the top jaw of the biter broke off.It was retrieved from the patient and the biter was replaced.The case was completed with no further issues and the patient is fine to date.

• Brand Name: MEGABITER, STRAIGHT 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
• MDR Report Key: 11842441
• Report Number: 1220246-2021-03110
• Device Sequence Number: 11720216
• Product Code: MDM
• UDI-Device Identifier: 00888867196339
• UDI-Public: 00888867196339
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/18/2021

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
• Device Lot Number: 73373
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1