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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Swelling/ Edema (4577)

Event Date 05/05/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, it was reported through the surgical outcome system that a revision surgery is required due to a deep infection and the patient experiencing excessive swelling and sepsis.The date of the primary procedure was on (b)(6) 2022 for a knee arthroscopic acl procedure where an acl tightrope abs and acl tightrope rt was implanted.No additional information was provided.Additional information requested.

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.

• Brand Name: UNK
• Type of Device: PIN, FIXATION, SMOOTH
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15041718
• MDR Text Key: 296061633
• Report Number: 1220246-2022-05257
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other