MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. IO FIX 2.0; BONE SCREW

Catalog Number 118-43045

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that an io fix 2.0 screw broke postoperatively.The surgeon believes it is a 45 x 4.3mm locking screw.The screw remains implanted.There are currently no plans to remove the device unless the patient does not fuse.

• Brand Name: IO FIX 2.0
• Type of Device: BONE SCREW
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany NJ 07054
• Manufacturer Contact: mary hoffman ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07504 ; 9735888980
• MDR Report Key: 19000239
• MDR Text Key: 338998331
• Report Number: 3007289093-2024-00004
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00842078105108
• UDI-Public: 00842078105108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 118-43045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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