MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT W/ DEPLOYING SUTURE; SMOOTH FIXATION PIN

Model Number	ACL TIGHTROPE RT W/ DEPLOYING SUTURE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
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 the device failed on the femoral side, a few months after a hamstring anterior cruciate ligament surgery was done on the patient.The patient has been walking down the stairs and fell, and the patient had instability following this.There was no visible damage to the tightrope loop; it appeared intact.However, the loop seems to have failed, resulting in laxity of the acl graft and its displacement from the femoral tunnel.A revision surgery was performed on the patient, during which arthroscopic images confirmed the loop's integrity.Subsequently, a bone-patellar tendon-bone (btb) reconstruction was carried out on june 3rd 2024 as a revision procedure.X- rays have also been taken to show the button is clearly in the correct position on the femoral side, and has not moved inside the tunnel.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.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 a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.Dfu-0147-eo; revision 2; e9 offers advisements for the patient to restrict activities and follow the physicians' directions during the healing period: " postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device and bone.".

• Brand Name: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• 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: 19654610
• Report Number: 1220246-2024-06545
• Device Sequence Number: 20559059
• Product Code: MBI
• UDI-Device Identifier: 00888867095533
• UDI-Public: 00888867095533
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown