MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FIBERTAPE
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 5th july 2025, it was reported by an arthrex employee via email that an ar-13999mf, fastpass scorpion, sl-mf, or needle kept cutting the suture when it was fired through cuff tissue.This had happened previously with the same scorpion instrument and a different needle so the arthrex employee queries whether the trap door is ok and if something needs to be repaired.This was detected during use in an unspecified procedure on (b)(6) 2025.(b)(6) 2025 - the complaint initiator replied that the procedure was completed successfully as another scorpion handpiece instrument was opened.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025 - the complaint initiator indicated that upon secondary review of the scorpion, the trap door of the instrument was observed to be damaged.It was also clarified that the issue with cutting the suture was not attributed to the needle but rather to the scorpion instrument.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is user error, including failing to inspect the instrument prior to use.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: FIBERTAPE
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 22674515
• Report Number: 1220246-2025-03161
• Device Sequence Number: 17100016
• Product Code: GAT
• UDI-Device Identifier: 00888867041769
• UDI-Public: 00888867041769
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2025

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
• Device Catalogue Number: AR-7237-7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 11/04/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/26/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown