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	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.The precise cause for the related condition could not be determined.Fragments were accounted for and found during investigation/evaluation process.
Event or Problem Description
It was reported that the suture cutter is not cutting.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.
Additional Manufacturer Narrative
The precise cause for the related condition could not be determined.Fragments were accounted for and found during investigation/evaluation process.

• 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: 11392550
• Report Number: 1220246-2021-02629
• Device Sequence Number: 3117648
• Product Code: MDM
• UDI-Device Identifier: 00888867005655
• UDI-Public: 00888867005655
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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 Model Number: SUTURE CUTTER, 4.2 MM, STRAIGHT
• Device Catalogue Number: AR-12250
• Device Lot Number: 10228638
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1