MAUDE Adverse Event Report: TYBER MEDICAL 4.0MM TI CANN COMPRESSION HEADLESS SCREW - LT - 40MM; TRAUMA SCREW

Model Number	04.334.440
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	01/18/2022
Type of Reportable Event	Malfunction
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, associated pain, and a non-union after 13.5 months.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
This submission is for the second device associated with 3012966183-2024-00018.Adverse event from the clinical study: at 9-months post-operative imaging demonstrated screw loose, radiolucency; the subject was ordered a bone growth stimulator and toe-off brace.At 11-months post-operative subject continued to have pain with ambulation and planned to continue to use bone growth stimulator and simultaneously schedule surgery to have hardware removed if no improvement is seen with bone growth stimulator; imaging demonstrated that the radiolucency remained visible however no new signs of loosening.At 12- months post-operative subject continued to use bone growth stimulator with no signs of increased healing; imaging shows radiolucency remained present.At 13.5-months post-operative subject underwent hardware removal surgery due to the nonunion.All hardware was removed during the procedure and was replaced with a different brand's system.Subject was terminated from the study upon removal of headless screws.

• Brand Name: 4.0MM TI CANN COMPRESSION HEADLESS SCREW - LT - 40MM
• 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
• MDR Report Key: 20498367
• Report Number: 3012966183-2024-00019
• Device Sequence Number: 18043081
• Product Code: HWC
• UDI-Device Identifier: 00819917024395
• UDI-Public: 00819917024395
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 04.334.440
• 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: 01/12/2023
• Initial Report FDA Received Date: 10/21/2024
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 71 KG