MAUDE Adverse Event Report: TYBER MEDICAL CANNULATED COMPRESSION HEADLESS SCREW; 4.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 30MM

Model Number	04.333.530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was identified during a retrospective clinical study.A historical data analysis and trend analysis were conducted revealing no identified trends or capas related to the nature of this complaint.A device evaluation was unable to be performed as the device is not available for testing.
Event or Problem Description
Adverse event captured as part of a retrospective clinical study: at 2 months post operative, one screw was noted to be broken.At 3 months post operative a second screw was noted to be broken as well.Foot was still considered stable at this time.Patient later underwent hardware removal of the broken screws at 1 year post op.

• Brand Name: CANNULATED COMPRESSION HEADLESS SCREW
• Common Device Name: 4.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 30MM
• 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 ; 8667610933
• MDR Report Key: 21411949
• Report Number: 3012966183-2025-00001
• Device Sequence Number: 8523914
• Product Code: HWC
• UDI-Device Identifier: 00819917024555
• UDI-Public: 00819917024555
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• 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): 02/19/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.333.530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 02/19/2025
• 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: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 108 KG