MAUDE Adverse Event Report: ARTHREX, INC. BTB TIGHTROPE W/ DEPLOYING SUTURE; SMOOTH FIXATION PIN

Model Number BTB TIGHTROPE W/ DEPLOYING SUTURE

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

On 05-oct-2022, it was reported by a sales rep via email that while using a ar-1588btb-j, btb tightrope w/ deploying suture, the tightrope was attached to the btb autograft via the specified technique.The tight rope would not lengthen or shorten on one side, the locking mechanism did not visually look like the other side which was sliding correctly.It appeared to have a loop of suture.This was discovered during use and a case was involved; however, the procedure was completed successfully.

Manufacturer Narrative

The device was not returned for evaluation; no pictures were provided.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; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Type of Device: SMOOTH FIXATION PIN
• 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: emily shafer ; 8009337001
• MDR Report Key: 18446799
• MDR Text Key: 332145368
• Report Number: 1220246-2024-00100
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Model Number: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-J
• Device Lot Number: 14463564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1