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	Insufficient Information (4580)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/2/2023, it was reported by a sales representative via phone that an ar-1288btbib-fc3 tightrope ii btb-ib implant system with flipcutter iii and fiberstick had an issue.The blade broke off when retrodrilling in the tunnel on the femur.The case was completed using another product with a different technique to drill the tunnel that the surgeon was unfamiliar with, which caused a case delay of an hour and thirty minutes with the additional thirty-minute delay to retrieve the fragments with no fragments left inside the patient.No additional anesthesia was administered.This was discovered during an acl reconstruction procedure on 11/2/2023.Additional information received on 11/4/2023: the case was completed using an ar-1400f-105 flexible reamer with a flexible guide pin 10.5mm and using a different technique to drill the tunnel, "flexible reamer, medial portal drilling," that the surgeon was unfamiliar with, which caused a case delay of an hour and thirty minutes with the additional thirty-minute delay to retrieve the fragments with no fragments left inside the patient.
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
This report is being submitted to provide additional information in d8/9, g3, h3, h6: health effect - clinical code, health effect - impact code, type of investigation, investigation findings, investigation conclusions, and h10, and updated information in g1.Complaint is confirmed.Visual inspection identified the distal end of the shaft of the flipcutter iii drill had twisted and broken.The btb tightrope® ii, with internalbrace¿ and #2 fiberwire braid blue of the btb ib tightrope w flipcutter iii drill were not returned.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error to misaligned insertion; prying/leveraging the device during insertion.

• 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: 18247768
• Report Number: 1220246-2023-09055
• Device Sequence Number: 7191343
• Product Code: MBI
• UDI-Device Identifier: 00888867379961
• UDI-Public: 00888867379961
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202581
• 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): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BTB IB TIGHTROPE W FLIPCUTTER III DRILL
• Device Catalogue Number: AR-1288BTBIB-FC3
• Device Lot Number: 15068833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown