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

Model Number	FIBERTAPE CUTTER
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
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
On 05/13/2024, a distributor reported via (b)(4) that an ar-13250 fibertape cutter was rusted and did not cut.This occurred during a case and had no effect on the patient.
Additional Manufacturer Narrative
The complaint allegation that the device is rusted is confirmed.One unpackaged ar-13250 fibertape cutter batch number: 67856 was received for evaluation.Visual inspection noted the device had wear and tear, the laser markings were almost completely faded, and there was discoloration observed near the suture cutter tip and throughout the device.Functional testing was performed by loading the ar-13250 fibertape cutter with a suture and attempting to cut it.The device was found to cut as intended.The complaint allegation that the ar-13250 fibertape cutter did not cut is not confirmed.The most likely cause for the reported failure of the device being rusted can be attributed to wear and tear.

• Brand Name: FIBERTAPE CUTTER
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 19496659
• Report Number: 1220246-2024-05347
• Device Sequence Number: 15137130
• Product Code: MDM
• UDI-Device Identifier: 00888867010413
• UDI-Public: 00888867010413
• 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: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 67856
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown