MAUDE Adverse Event Report: ARTHREX, INC. TRANSTIBIAL ACL DISPOSABLE; GUIDE WIRE, NITINOL

Model Number AR-1898S

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/11/2017

Event Type  malfunction  

Event Description

A nitinol wire was positioned for second acl screw.Tried to pull out the nitinol wire and was not able to remove.The surgeon used a pair of pliers on the wire and used a mallet to "bang" out the wire.The wire then broke inside the femur and inside part of the screw.A mini c-arm was used to verify that wire was in the joint.Surgeon confirmed wire was not in joint and wire not retrieved.Approximately, two centimeter piece remains in patient bone.

• Brand Name: TRANSTIBIAL ACL DISPOSABLE
• Type of Device: GUIDE WIRE, NITINOL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 6964478
• MDR Text Key: 89825524
• Report Number: 6964478
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AR-1898S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR