MAUDE Adverse Event Report: ARTHREX, INC. SUTURE CUTTER, 4.2 MM, STRAIGHT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	SUTURE CUTTER, 4.2 MM, STRAIGHT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpackaged ar-12250, batch 67482 suture cutter was received for investigation.Visual inspection identified that the functionality of the cutter tip was impeded due to breakage of the distal end of the device at the tip pin.The broken portion of the cutter was retained at the distal end of the device, although only one of the two pins at the tip could be visualized.Although the components at the cutter tip could not be accurately measured due to the degree of damage present, the overall suture cutter shaft fell within design specifications.The observed condition is most likely the result of dropping the device or smashing the device into solid materials.
Event or Problem Description
It was reported that during a shoulder arthroscopic procedure, the tip of the ar-12250 would not work.The case was completed by using a new ar-12250 without further issue.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: SUTURE CUTTER, 4.2 MM, STRAIGHT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12268662
• Report Number: 1220246-2021-03482
• Device Sequence Number: 11897673
• Product Code: MDM
• UDI-Device Identifier: 00888867005655
• UDI-Public: 00888867005655
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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: SUTURE CUTTER, 4.2 MM, STRAIGHT
• Device Catalogue Number: AR-12250
• Device Lot Number: 67482
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1