MAUDE Adverse Event Report: TYBER MEDICAL CANNULATED SCREW SYSTEM +; 7.5MM TI CANN SCREW + FT - 95MM

Model Number	04.355.895
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was evaluated and investigated with the currently available information.The impacted device was not returned; therefore a device evaluation was unable to be performed.A device history record review was unable to be performed for lot related nonconformities, as no identifying lot information was made available.A historical data analysis identified no trends related to the nature of this event.The root cause cannot be established with the available information.
Event or Problem Description
It was reported on (b)(6) 2026 as surgeon was implanting screw the head snapped off.Surgeon was able to retrieve broken screw with minimal damage to surrounding bone.This extended surgery approximately 30 minutes to remove and implant new screw.

• Brand Name: CANNULATED SCREW SYSTEM +
• Common Device Name: 7.5MM TI CANN SCREW + FT - 95MM
• 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: 25160835
• Report Number: 3012966183-2026-00004
• Device Sequence Number: 13446188
• Product Code: HWC
• UDI-Device Identifier: 00810040681219
• UDI-Public: 00810040681219
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K252901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 04.355.895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/13/2026
• 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: Other; Required Intervention
• Patient Sex: Unknown