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

Model Number	TIGHTROPE, ABS, IMPLANT
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/25/2021
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 during an anterior cruciate ligament reconstruction while tightening the loop could not be knotted.The surgeon switched to a fixation with a vilagro screw to finish the procedure successfully.On 30-aug-2021 update dw: further information were provided that the graft was prepared in a "graft link" manner with tightrope rt on the femoral and tightrope abs on the tibial side.The tibial tunnel was drilled through completely and the surgeon placed graft in the fem.Tunnel and fixated it on cortex.Procedure was continued with fixating graft on the tibial side but when the abs tightrope loop should lock over the abs button the system didn't lock and the loop stayed loose.As the fixation did not work the surgeon placed additional interference screw in tibial tunnel and fixated the graft.The surgeon removed the abs button but remained the tightrope inside the patient.

• Brand Name: TIGHTROPE, ABS, IMPLANT
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12467743
• Report Number: 1220246-2021-03655
• Device Sequence Number: 17077657
• Product Code: HTY
• UDI-Device Identifier: 00888867019706
• UDI-Public: 00888867019706
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K110213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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 Expiration Date: 10/31/2025
• Device Model Number: TIGHTROPE, ABS, IMPLANT
• Device Catalogue Number: AR-1588TN
• Device Lot Number: 12032432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other