MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE; SMOOTH FIXATION PIN

Model Number	ACL TIGHTROPE
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-1588t serial/batch number (b)(6) was received for investigation.The returned device was visually inspected, and it was noted that the ends of the suture were pulled on the same side of the loops/wedges.Upon fixing the assembly of the device.The functional test found that loops were open/closed without issues.The most likely cause(s) of reported failure is user error.According to dfu-0147-eor2.G.Precautions.1.Acl/pcl/btb/rt/abs tightrope only: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands and impair ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket and the graft stability is verified by pulling distally on the graft.3.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.
Event or Problem Description
On 3/28/2023, it was reported by an arthrex employee via email that an ar-1588t acl tightrope did not tip over.The surgeon pulled the sutures to tumble; the mesh was triggered.When the graft came back, the button when down together.Additional information received on 5/8/2023: this was discovered during an acl procedure on (b)(6) 2023.The surgeon pulled on the sutures to tighten but the button did not turn and was unable to lock.Nothing broke off inside the patient and the sutures and button were removed.The case was completed using an ar-1400tb bio-interference screw.

• Brand Name: ACL TIGHTROPE
• Common Device Name: SMOOTH FIXATION PIN
• 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: 19489242
• Report Number: 1220246-2024-05226
• Device Sequence Number: 7024970
• Product Code: MBI
• UDI-Device Identifier: 00888867019614
• UDI-Public: 00888867019614
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K231857
• 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
• Report Date (Section B): 06/07/2024

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: ACL TIGHTROPE
• Device Catalogue Number: AR-1588T
• Device Lot Number: 14997072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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