MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. X-RING FIXATOR; EXTERNAL FIXATION SYSTEM

Catalog Number	156-62230-HAS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient got the tibial half pin caught on his wheelchair and sheared it off at the cortex pin interface.The half pin was replaced.

• Brand Name: X-RING FIXATOR
• Common Device Name: EXTERNAL FIXATION SYSTEM
• 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: 23417106
• Report Number: 3007289093-2025-00011
• Device Sequence Number: 10300105
• Product Code: KTT
• UDI-Device Identifier: 00842078135501
• UDI-Public: (01)00842078135501(11)250407(17)350407(10)2309-13
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 156-62230-HAS
• Device Lot Number: 2309-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male