MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ABS, 14 MM BUTTON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder surgery the button broke in the middle.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device by using only the sutures.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.- one unpackaged ar-1588tb-1, tightrope® abs, button, batch 15299791, was returned for investigation.- visual evaluation of the device noted that the button was broken along the middle.- functional testing was not performed due to the damage to the device.- the most likely cause of the reported failure is misuse, which occurred when tightening the suture when the button was not completely flush on the bone.The button must be leveled out.- refer to investigation photos.- the complaint allegation is confirmed.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 23027650
• Report Number: 1220246-2025-03814
• Device Sequence Number: 13140116
• Product Code: MBI
• UDI-Device Identifier: 00888867019638
• UDI-Public: (01)00888867019638(11)240808(17)290731(10)15299791
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K241235
• 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): 10/09/2025

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: 15299791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown