MAUDE Adverse Event Report: MEDARTIS INC. STEALTHFIX INSTROSSEOUS FIXATION SYSTEM; STAPLE

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

If addtional information is provided that changes the outcome of the investigation, a follow-up report will be filed.

Event Description

Per dr.Coetzees notes the patient has painful hardware following left midfoot fusion ((b)(6) 2023).Per implant records the patient has 2 stealthfix staples sf451520 and sf351520.Left food hardware removal scheduled for (b)(6) 2023.

• Brand Name: STEALTHFIX INSTROSSEOUS FIXATION SYSTEM
• Type of Device: STAPLE
• Manufacturer (Section D): MEDARTIS INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer (Section G): MEDARTIS INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer Contact: travis christman ; 1195 polk drive; warsaw, IN 46582
• MDR Report Key: 18022316
• MDR Text Key: 326744305
• Report Number: 3009450749-2023-00007
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K232324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1