MAUDE Adverse Event Report: TYBER MEDICAL 5.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 42MM; TRAUMA SCREW

Model Number	04.333.642
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561); Radiolucent Lines (4848)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted for an event that was identified as part of a historical data review comparing clinical trial adverse events with the vigilance system.The event was investigated without the affected device or specific device lot information.The device was discarded, therefore a device evaluation could not be performed.Upon review of clinical records, a specified device malfunction could not be established, however radiolucency was observed around the implant.The device was removed from the patient as a result of the radiolucency and associated pain.A historical data analysis was conducted returning no related complaints, nonconformities, or capas associated with the part number.Due to insufficient information regarding a device defect, the root cause cannot be established.
Event or Problem Description
Per clinical study report: at 4-months post-operative the patient was not fused and was deemed to have a painful nonunion with the screws loose and radiolucency around the screws.At 5-months post-operative the subject had revision surgery to remove the cchs screws: an ankle arthrodesis with an anterior approach was performed using an effusion plate and bone graft.To remove the cchs screws: an ankle arthrodesis with an anterior approach was performed using an effusion plate and bone graft.Subject was terminated from the study upon removal of headless screws.

• Brand Name: 5.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 42MM
• Common Device Name: TRAUMA SCREW
• 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: 20485618
• Report Number: 3012966183-2024-00015
• Device Sequence Number: 17047688
• Product Code: HWC
• UDI-Device Identifier: 00819917025170
• UDI-Public: 00819917025170
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 04.333.642
• 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: 05/13/2021
• Initial Report FDA Received Date: 10/18/2024
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 135 KG