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

Model Number	MINI SUTURE CUTTER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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 the cutter broke when cutting labral tape.Nothing went into the patient and the labral repair was completed.
Additional Manufacturer Narrative
The related condition is typically caused by applying excessive force while attempting to cut suture and/or an excessive amount of suture at one time.Fragments were accounted for and found during investigation/evaluation process.Function test could not be performed due to related condition.

• Brand Name: MINI SUTURE CUTTER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11613216
• Report Number: 1220246-2021-02833
• Device Sequence Number: 3498238
• Product Code: MDM
• UDI-Device Identifier: 00888867010451
• UDI-Public: 00888867010451
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/07/2021

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: MINI SUTURE CUTTER
• Device Catalogue Number: AR-13255
• Device Lot Number: 10221530
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 09/07/2021
• Patient Sequence Number: 1