MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE CERCLAGE W/O NEEDLE; FIXATION CERCLAGE

Model Number	FIBERTAPE CERCLAGE W/O NEEDLE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic surgery the device tore.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-7268 serial/batch number (b)(6) was received for evaluation.Upon visual inspection it was noted that the device was disassembled, only the sutures were returned for evaluation.Frayed was noted on the tip of the blue suture.The most likely cause of the reported failure is a user error excessive forces during tensioning.Directions for use.Dfu-0264-eor4_fmt_en.Fibertape® and tigertape¿ cerclage sutures and radiopaque fibertape® cerclage sutures.1.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.2.Assure that all knots have been secured using accepted surgical knot tying techniques.Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon.The use of additional throws may be particularly appropriate when knotting monofilaments.Care should be taken to prevent damage to surrounding tissue or user puncture due to improper handling of the needlepoint.3.Do not grasp the needle at the point or swage to avoid damage to these areas.Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.Discard used needles in ¿sharps¿ containers.4.Avoid wrapping the suture over sharp metal or bone graft surfaces.

• Brand Name: FIBERTAPE CERCLAGE W/O NEEDLE
• Common Device Name: FIXATION CERCLAGE
• 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: 21353905
• Report Number: 1220246-2025-00364
• Device Sequence Number: 21113907
• Product Code: GAT
• UDI-Device Identifier: 00888867369894
• UDI-Public: (01)00888867369894(11)240221(17)290131(10)15210450
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K232755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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 CERCLAGE W/O NEEDLE
• Device Catalogue Number: AR-7268
• Device Lot Number: 15210450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown