MAUDE Adverse Event Report: ARTHREX, INC.; NON-DEGRADABLE FIXATN FASTENER

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Foreign Body Reaction (1868)

Event Date 03/10/2022

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 (b)(6) 2023, it was reported by a patient via phone that an allergic reaction occurred after a left foot reconstruction procedure on (b)(6) 2022.The patient has reported recurring hives, blister, redness, itchiness, and scarring in the incision site since the procedure.Per the patient, a swivelock and fibertak sutures were implanted; however, part numbers are unknown.Additional information received on 3/29/2023: arthrex mini suturetak anchors were also implanted during the procedure on (b)(6) 2022.

• Brand Name: UNK
• Type of Device: NON-DEGRADABLE FIXATN FASTENER
• 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: 16838858
• MDR Text Key: 314259641
• Report Number: 1220246-2023-06607
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2023
• 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