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

Model Number	FIBERTAPE CUTTER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
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 a procedure, the ar-13250, break while cutting two fibertapes.No fragments broke off in the shoulder, and the case was completed by using a new ar-13250.

• Brand Name: FIBERTAPE CUTTER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11630907
• Report Number: 1220246-2021-02858
• Device Sequence Number: 11517077
• Product Code: MDM
• UDI-Device Identifier: 00888867010413
• UDI-Public: 00888867010413
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 04/07/2021

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: FIBERTAPE CUTTER
• Device Catalogue Number: AR-13250
• Device Lot Number: 79016
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/07/2021
• Patient Sequence Number: 1