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	Failure of Implant (1924)
Date of Event	11/29/2021
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 that during a rotator cuff shoulder arthroscopy surgery the device broke, and the upper jaw was loose in the joint.The surgeon was able to retrieve the jaw, and there where no additional loose bodies in the joint.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
Event or Problem Description
It was reported that during a rotator cuff shoulder arthroscopy surgery the device broke, and the upper jaw was loose in the joint.The surgeon was able to retrieve the jaw, and there where no additional loose bodies in the joint.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.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
Complaint confirmed.One unpackaged ar-41026 was received for investigation.Visual inspection identified that the cutter had broken from the body of the megabiter at the connection point with the actuator.Fragments of the cutter and the curved actuator were returned along with the main assembly.The cause remains undetermined, although a probable cause is attributed to the application of leveraging forces on the distal end 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: 13054392
• Report Number: 1220246-2021-04135
• Device Sequence Number: 17439559
• Product Code: MDM
• UDI-Device Identifier: 00888867032743
• UDI-Public: 00888867032743
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 02/03/2022

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: 59133
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown