MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; SMOOTH FIXATION PIN

Model Number	TIGHTROPE ABS, 14 MM BUTTON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11th january 2024, it was reported by a distributor via email that an ar-1588tb-1, tightrope® abs, button, round, ø 14 mm, broke in half during the last step of the procedure when our scrub nurse tech assisted the surgeon in putting the abs button on the tibial side and it broke in half during the final tension by pulling the tightrope.This was detected during use in a knee acl all inside procedure on (b)(6) 2024.The procedure was completed successfully with a second button.
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.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-1588tb-1 serial/batch number (b)(6) was received for investigation.The visual evaluation revealed that the 14mm abs button was broken in half.The thickness of both halves was measured using a blade micrometer and found that the dimensions were 0.056 and 0.055 which are in tolerance of the specified.059 ±.005 by drawing c6342 at revision 1.The functional testing was not performed due to the damaged.The most likely cause for the observed failure is excessive force apply during the tensioning.According to dfu-0147.At revision 2.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.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• 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: emily shafer ; 8009337001
• MDR Report Key: 18629096
• Report Number: 1220246-2024-00687
• Device Sequence Number: 15412708
• Product Code: HTY
• UDI-Device Identifier: 00888867019638
• UDI-Public: 00888867019638
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K110123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: TIGHTROPE ABS, 14 MM BUTTON
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 15128855
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• 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