MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, 3.5MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	DISSECTOR, 3.5MM X 13CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
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.
Event or Problem Description
It was reported that during the usage of the shaver the device quickly bent and the blade inside broke.The device broke inside the patient and no broken parts remained inside the patient.There was no harm or adverse event for patient, operator or third party reported.The suture of the rotator cuff 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
Complaint confirmed.One unpackaged ar-8350ds dissector (labeled with component batch 47682042) was received for investigation.Visual inspection identified that the outer tube shaft was severely bent at the connection point with the outer hub.When removing the inner tube component from the outer tube, it was discovered that the inner tube had broken within the outer tube.The distal tip of the inner tube was visible through the outer tube window.Using micro-vu id: 654, it was determined that the inner tube broke at approximately 22.67 mm from the inner hub.The remainder of the shrink tubing on the inner tube fragment was noted to be damaged, consistent with the bending observed at the proximal end of the outer tube.Material analysis testing identified that the device met all as-received specifications.This event is consistent with user applied mechanical damage via prying/leveraging against bone and/or hard tissue.

• Brand Name: DISSECTOR, 3.5MM 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: 11540375
• Report Number: 1220246-2021-02757
• Device Sequence Number: 4108404
• Product Code: GFA
• UDI-Device Identifier: 00888867043299
• UDI-Public: 00888867043299
• 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,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: DISSECTOR, 3.5MM X 13CM
• Device Catalogue Number: AR-8350DS
• Device Lot Number: 12160750
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 06/04/2021
• Patient Sequence Number: 1