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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2024
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 07/15/2024, it was reported by a sales representative via email that the tightrope suture from an ar-1288btbib-fc3 btb ib tightrope with flipcutter iii drill was knotted.The sutures that wrap around the number two section of the card were jumbled in a knot and it was not noticed until after the conversion was made for the tightrope.The knot in the suture prevented tensioning of the implant.Everything was cut out, and a second ar-1288btbib-fc3 btb ib tightrope with flipcutter iii drill kit was used to complete the case.This was discovered during an acl bone tendon bone reconstruction procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue with the assembly process; however, due to the device not being returned, we are unable to confirm the reported event.

• 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: 20065379
• Report Number: 1220246-2024-07265
• Device Sequence Number: 18098078
• Product Code: MBI
• UDI-Device Identifier: 00888867379961
• UDI-Public: 00888867379961
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• 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): 06/19/2025

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: 15219020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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