MAUDE Adverse Event Report: ARTHREX, INC. BTB IB TIGHTROPE W FLIPCUTTER III DRILL; NON-DEGRADABLE FIXATN FASTENER

Model Number	BTB IB TIGHTROPE W FLIPCUTTER III DRILL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
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 (b)(6) 2025, it was reported by a sales representative via phone that an ar-1288btb-ib- fc3 internal brace flipcutter blade broke during initial drilling.This occurred during use in a case with no patient effect.Case completed using another flipcutter.All fragments removed.No delay to case.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1288btbib-fc3 serial/batch (b)(6) was received for evaluation.Functional testing was conducted by activating the deploy button.No movement of the cutting blades was observed, which was attributed to the break.A visual inspection revealed that the blade shaft had detached at the weld.It was noted nicks in the cutting tip and scratches in the shaft.The most likely cause of the reported and observed device failure is user error, specifically misalignment of the insertion and/or the device making contact with another instrument during use.The complaint allegation was confirmed.

• Brand Name: BTB IB TIGHTROPE W FLIPCUTTER III DRILL
• 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: 22044431
• Report Number: 1220246-2025-02095
• Device Sequence Number: 8781532
• Product Code: MBI
• UDI-Device Identifier: 00888867379961
• UDI-Public: (01)00888867379961(11)250114(17)280930(10)15373026
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 08/28/2025

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: BTB IB TIGHTROPE W FLIPCUTTER III DRILL
• Device Catalogue Number: AR-1288BTBIB-FC3
• Device Lot Number: 15373026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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