MAUDE Adverse Event Report: TYBER MEDICAL CANNULATED SCREW SYSTEM +; 3.5MM TI CANN SCREW + LT - 50MM

Model Number	04.354.350
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was investigated without the impacted device or relevant lot information.Without the device or lot information, a device evaluation or device history record review could not be performed.A historical data analysis concluded there were no trends or capas related to the nature of this complaint.The cause of the event can be traced to component failure; however, the underlying root cause cannot be established without evaluation of the impacted device.
Event or Problem Description
It was reported that on (b)(6) 2025 while surgeon was implanting a 3.5x50mm css+ screw in a young patient with good bone.Outer cortex and initial 1cm of bone was drilled with 2.7mm drill as per technique.The screw was placed over 1.4mm wire and surgeon attempted to insert under power.Halfway through trajectory, a loud cracking sound was heard and the screw stopped advancing.An x ray shot was taken and the screw had fractured right at the junction between the smooth barrel of the screw and the threaded portion.The following 45 minutes were spent retrieving the broken portion of the screw that was embedded in the patient.Was difficult to remove fractured screw piece, had to trephine out the bone around screw, fragment was successfully removed.There was no patient consequences.

• Brand Name: CANNULATED SCREW SYSTEM +
• Common Device Name: 3.5MM TI CANN SCREW + LT - 50MM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 s commerce way; bethlehem, PA 18017
• MDR Report Key: 21943164
• Report Number: 3012966183-2025-00009
• Device Sequence Number: 9056452
• Product Code: HWC
• UDI-Device Identifier: 00810040632631
• UDI-Public: 00810040632631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.354.350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 05/01/2025
• 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; Other
• Patient Age: 14 YR
• Patient Sex: Male