MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. 4.0 X 100MM CANN SCREW FASTENER LONG THD; CANNULATED FASTENER

Model Number	320-40100-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the head of a 4.0mm cannulated fastener detached while being implanted in the patient's right distal fibula.The surgeon intended to use the 4.0mm cannulated fastener as an "im nail" construct, but the 4.0mm cannulated fastener is not part of an "im nail" system.While under power, the head separated from the shaft, and the surgeon was only able to partially remove the fastener.Part of the implant remains in the fibular canal.The surgeon completed the procedure using a lateral distal fibular plate for final reduction and fixation.No adverse patient outcomes were reported.
Additional Manufacturer Narrative
The device was unavailable for evaluation as it is currently implanted.Manufacturing and inspection records were reviewed with no abnormalities found.The detachment of the 4.0mm cannulated fastener head occurred due to the fastener being used as an "im nail" construct, despite it not being part of an "im nail" system.
Additional Manufacturer Narrative
Udi related data quality updates & product information update: this follow-up report includes the full udi, which was missing from the initial report.This report specifies that this is not a combination product.

• Brand Name: 4.0 X 100MM CANN SCREW FASTENER LONG THD
• Common Device Name: CANNULATED FASTENER
• Manufacturer (Section D): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• Manufacturer (Section G): OSTEOCENTRIC TECHNOLOGIES, INC; 75 w 300 n; suite 150; logan, UT 84321
• Manufacturer Contact: todd evans ; 75 w 300 n; suite 150; logan, UT 84321 ; 4357572253
• MDR Report Key: 20967952
• Report Number: 3011656326-2024-00003
• Device Sequence Number: 4196002
• Product Code: HWC
• UDI-Device Identifier: 00810074303712
• UDI-Public: (01)00810074303712
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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 Model Number: 320-40100-02
• Device Catalogue Number: 320-40100-02
• Device Lot Number: ECW152
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• 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: Other
• Patient Age: 20 YR
• Patient Sex: Female