MAUDE Adverse Event Report: TYBER MEDICAL CANNULATED COMPRESSION HEADLESS SCREW; 2.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 24MM

Model Number	04.333.124TS
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was investigated and evaluated through radiographic imaging review, third party medical consultation, and the provided information from the complainant.The impacted device remains implanted; therefore a device evaluation could not be performed.A historical data analysis for the device and lot numbers returned no associated nonconformities related to the nature of this complaint.With the current information available, a root cause cannot be established.
Event or Problem Description
As reported by the complainant: case involves a 12-year-old girl with a pseudoarthrosis.Fortunately, the pseudoarthrosis has consolidated, so the screw can be removed in the near future.The surgery took place on 16/01/25.The control photos have the date visible, but here too, there's a more or less immediate failure.The pseudoarthrosis has consolidated, and the screw will be removed soon, with no revision required.

• Brand Name: CANNULATED COMPRESSION HEADLESS SCREW
• Common Device Name: 2.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 24MM
• 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: 22350832
• Report Number: 3012966183-2025-00014
• Device Sequence Number: 12889834
• Product Code: HWC
• UDI-Device Identifier: 00819917027211
• UDI-Public: 00819917027211
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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: 04.333.124TS
• Device Lot Number: 252892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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: 12 YR
• Patient Sex: Female