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

Model Number	FIBERTAPE CUTTER
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported on 12/06/2022 by a sales representative via sems that an ar-13250 fibertape cutter jaw snapped off.Case involvement, device broke during use.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, it was noted that the cutter tip is broken.The most probably cause is by applying excessive force while grasping and manipulating tissue or when applying excessive leveraging forces.No broken parts were returned for investigation.Functional testing was not performed due to the damage of the device.The cause remains undetermined.

• Brand Name: FIBERTAPE CUTTER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16051449
• Report Number: 1220246-2022-05974
• Device Sequence Number: 12276779
• Product Code: MDM
• UDI-Device Identifier: 00888867010413
• UDI-Public: 00888867010413
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 14949782
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown