MAUDE Adverse Event Report: ARTHREX, INC.; SMOOTH FIXATION PIN

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2023

Event Type  malfunction  

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.

Event Description

On 5/26/2023, it was reported by a distributor via sems that an ar-1588tnt acl-fibertag tightrope abs needle broke off the suture after the first pass through the quad tendon.A free needle was opened but the surgeon met resistance and did not properly pass through the fibertag.Another ar-1588tnt acl-fibertag tightrope abs was used to complete the case.This was discovered during a quads tendon aclr procedure on (b)(6) 2023.Additional information received on 6/8/2023: the needle broke off inside the patient, and all the fragments were retrieved.

• Brand Name: UNK
• 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: 17576951
• MDR Text Key: 321523469
• Report Number: 1220246-2023-07567
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/18/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 08/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1