MAUDE Adverse Event Report: ARTHREX, INC. FIBERLOOP, #2, BLUE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FIBERLOOP, #2, BLUE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
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
It was reported that during an anterior cruciate ligament reconstruction with semitedinosus tendon the device fell apart.There was no harm for patient, operator or third party reported.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
Additional information: d9, g3, h3, h6.The complaint allegation is not confirmed as the complaint device was not received for evaluation.Four sealed packaged ar-7234 serial/batch number 15068356 were received for evaluation.The complaint allegation device was not received for evaluation.Two packages were open, and upon visual inspection, the suture needle and assembly were free of defects.According to drawing c1283, the nitinol loop must withstand a 5 lb straight pull.When the device¿s documentation was reviewed, no issues were found.The device passed the pull functional test.Functional testing was performed by applying manual tension to the suture to replicate suture tensioning, and no issues were noted.The needle was not observed to loosen or detach.No problem was found with the sealed package received devices.The most likely cause of the reported failure is a user error.Direction for use.Dfu-0222-eor2_fmt_en.G.Precautions.2.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.

• Brand Name: FIBERLOOP, #2, BLUE
• 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: 19630043
• Report Number: 1220246-2024-06483
• Device Sequence Number: 7400010
• Product Code: GAT
• UDI-Device Identifier: 00888867041677
• UDI-Public: 00888867041677
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122374
• 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): 12/30/2024

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: FIBERLOOP, #2, BLUE
• Device Catalogue Number: AR-7234
• Device Lot Number: 15068356
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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