MAUDE Adverse Event Report: ARTHREX, INC. SCISSORS, 3.4 MM, STRAIGHT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SCISSORS, 3.4 MM, STRAIGHT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/14/2021, it was reported during a maude review, that when the surgeon inserted an ar-12140 scissors into the patient's shoulder and the device was opened, the ar-12140 would not close.This was discovered during use in a shoulder arthroscopy on (b)(6) 2021.The device was removed from the patient and the case was completed with a new ar-12140.
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.

• Brand Name: SCISSORS, 3.4 MM, STRAIGHT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12569286
• Report Number: 1220246-2021-03719
• Device Sequence Number: 14349151
• Product Code: LXH
• UDI-Device Identifier: 00888867005181
• UDI-Public: 00888867005181
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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: SCISSORS, 3.4 MM, STRAIGHT
• Device Catalogue Number: AR-12140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1