MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II ABS, IMPLANT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	TIGHTROPE® II ABS, IMPLANT
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/24/2023
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
On 05/24/2023, it was reported by a sales representative via phone that an ar-1588tn-20 tightrope implant would not tighten.This was discovered during a case.Surgeon diverted from intended procedure to use a swivellock to complete.
Additional Manufacturer Narrative
The complaint cannot be confirmed without the return of the device for evaluation.Per event description: "an ar-1588tn-20 tightrope implant would not tighten." it is concluded that the implant was not tightened.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure is a user error per dfu-0147 g.Precautions 1.Acl/pcl/ btb/rt/abs tightrope only: excessive force on the shortening suture strands 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.

• Brand Name: TIGHTROPE® II ABS, IMPLANT
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17152444
• Report Number: 1220246-2023-06920
• Device Sequence Number: 17566685
• Product Code: MBI
• UDI-Device Identifier: 00888867371897
• UDI-Public: 00888867371897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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: TIGHTROPE® II ABS, IMPLANT
• Device Catalogue Number: AR-1588TN-20
• Device Lot Number: 15028688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown