MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	DISSECTOR, 4.0MM X 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2021
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 meniscal surgery the shaver blade did break off.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8400ds was received for investigation.It was identified using digital caliper id: 011 that approximately 3.1" of the ar-8400ds shaft had broken off of the main assembly.The cutting head was retained within the outer tube hood.The breakage sites at both the distal end of the remainder of the assembly, as well as the breakage site at the proximal end of the fragment, were noticeably bent.As such, this event is consistent with user applied mechanical forces via prying/leveraging the device against bone and/or hard tissue.

• Brand Name: DISSECTOR, 4.0MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12333051
• Report Number: 1220246-2021-03517
• Device Sequence Number: 3935836
• Product Code: GFA
• UDI-Device Identifier: 00888867043572
• UDI-Public: 00888867043572
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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 Expiration Date: 04/30/2026
• Device Model Number: DISSECTOR, 4.0MM X 13CM
• Device Catalogue Number: AR-8400DS
• Device Lot Number: 13389514
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1