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

Device Problem Unintended Movement (3026)

Patient Problem Discomfort (2330)

Event Date 02/15/2023

Event Type  Injury  

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 8/25/2023, it was reported by a patient via phone that an ar-13070l-s patella sutureplate ii and (11) ar-5051-x low profile screws are making loud grinding noise with a range of motion.When the patient's knee is bent at sixty degrees, the implants hit the tibia, making an audible destructive sound.The procedure was performed on (b)(6) 2022.The patient started to experience the grinding noise sometime in (b)(6) 2023, which has worsened since then.The surgeon has taken x-rays and discharged the patient from physical therapy as the surgeon recommends revision surgery for hardware removal.The revision surgery has not been scheduled as of yet.The patient contacted arthrex to get a percentage of the patients with this specific implant undergoes hardware removal.

• 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: 17775095
• MDR Text Key: 323749996
• Report Number: 1220246-2023-07946
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2023
• 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
• Patient Outcome(s): Other