MAUDE Adverse Event Report: ARTHREX, INC. BUTTON INSERTER/SUTURE KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	BUTTON INSERTER/SUTURE KIT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 8/26/2024, it was reported by a sales representative via email that tightrope sutures ripped during tensioning.An ar-1670ps peek tenodesis screw was opened, and it was stripped during insertion.The case was completed using an ar-2280 knotless distal biceps and a new screw.This was discovered during a distal bicep procedure on (b)(6) 2024.Additional information received on 9/9/2024: the sutures of a knotless bicep button from an ar-2280 ripped, and the bicep was unable to be tightened.Everything was successfully removed from inside the patient.Ar-1670ps peek tenodesis screw did not break, only stripped during insertion.The case was completed using a new ar-1670ps peek tenodesis screw and ar-2280 knotless distal biceps.Additionally, during the procedure, when an ar-1255-18 suture passing wire was opened, it was missing the eyelet loop at the end.A second ar-1255-18 suture passing wire was used instead.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 9/9/2024: the sutures of a knotless bicep button from an ar-2280 ripped, and the bicep was unable to be tightened.Everything was successfully removed from inside the patient.Ar-1670ps peek tenodesis screw did not break, only stripped during insertion.The case was completed using a new ar-1670ps peek tenodesis screw and ar-2280 knotless distal biceps.Additionally, during the procedure, when an ar-1255-18 suture passing wire was opened, it was missing the eyelet loop at the end.A second ar-1255-18 suture passing wire was used instead.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: BUTTON INSERTER/SUTURE KIT
• 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: 20200954
• Report Number: 1220246-2024-07566
• Device Sequence Number: 7546363
• Product Code: MBI
• UDI-Device Identifier: 00888867097896
• UDI-Public: 00888867097896
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• 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,Followup
• Report Date (Section B): 07/03/2025

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: BUTTON INSERTER/SUTURE KIT
• Device Catalogue Number: AR-2280
• Device Lot Number: 15183526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/09/2024; 06/09/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/19/2024; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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