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

Model Number	TIGHTROPE, ABS, IMPLANT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2020
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.
Event or Problem Description
An arthrex employee has reported that during an all-inside graftlink anterior and posterior cruciate ligament surgery the abs tightrope implant came 'undone' with two separate implants during one procedure.The implants both failed through the same method.One of the white sutures used to toggle and reduce the loop of the abs came out of the locking construct of the tightrope backwards so the loop unraealled and became unusable.This occurred during graft preparation so there was no major issue the fault implant was just disposed of and a new abs implants opened.However the second time this happened was whilst the implant was being shuttled down the tibial socket for the posterior curciate ligament so caused delay in surgery as the graft had to be retrieved from the joint and a btb tightrope ar-1588btb was used to get inside the already prepared graftlink to finish the surgery successfully.*** update 15-sep-2020 further information was provided that the surgery time was extended by approximately 20 minutes.

• 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: 10631101
• Report Number: 1220246-2020-02206
• Device Sequence Number: 16972033
• Product Code: HTY
• UDI-Device Identifier: 00888867019706
• UDI-Public: 00888867019706
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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: 10/31/2024
• Device Model Number: TIGHTROPE, ABS, IMPLANT
• Device Catalogue Number: AR-1588TN
• Device Lot Number: 10464118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other