MAUDE Adverse Event Report: TYBER MEDICAL 5.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 50MM; TYBER MEDICAL CCHS TRAUMA SCREW

Model Number	04.334.650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated under magnification, revealing wear and damage within the hexalobe, indicating excessive force during screw insertion.The screw's shaft was also found to be deformed into a curve, suggesting that the screw experienced both transverse shear and torsional shear stress.Further evidence of combined loading is observed in the fracture pattern at the failure site, where part of the fracture peels inward towards the central axis of the screw at the point of intersection with the outer edge of the screw's deformed curvature.Measurements were taken of the device's shaft diameter and cannulation diameter, and both features were found to be within device specifications (shaft diameter: 2.999mm, cannulation diameter: 1.764mm), so adequate wall thickness was present.All devices within lot 200831 were found to meet specification through inspections performed both internally at tyber medical and externally by the component supplier.A device evaluation found that adequate wall thickness was present on the implant to retain structural integrity.Evidence of combined transverse and torsional loading suggests that the failure is user related, although a conclusive assessment of user error cannot be made without imaging from the procedure.The root cause of the failure, however, cannot be traced to the device.
Event or Problem Description
Reported from customer: procedure: foot surgery.It was reported that on (b)(6) 2024 5.5mm cchs 50mm screw broke during insertion.Surgery was completed successfully with 30 mins of surgical delay.Part of the broken screw was removed and the surgeon bone grafted the fracture site.Fragments were generated.Patient outcome was unknown.The screw was broken in to 3 pieces and 2 of the pieces were retained.5.5mm cchs 50mm screw broke during insertion: was surgery delayed due to the reported event? yes.If yes, number of minutes: 30 min.Action taken when event occurred? part of the broken screw was removed and the surgeon bone grafted the fracture site.Was procedure successfully completed? yes.Were fragments generated? yes.If yes, were they removed easily without additional intervention? no.Patient status/ outcome / consequences: patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? not at this time.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.Tyber medical retrieved additional information from customer: the cchs (cannulated compression headless screw) broke into 3 pieces.Only 1 part was retrievable.The other 2 parts were left implanted.

• Brand Name: 5.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 50MM
• Common Device Name: TYBER MEDICAL CCHS 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: 19760449
• Report Number: 3012966183-2024-00008
• Device Sequence Number: 15099689
• Product Code: HWC
• UDI-Device Identifier: 00819917025224
• UDI-Public: 00819917025224
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/16/2024

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
• Device Model Number: 04.334.650
• Device Lot Number: 200831
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2020
• 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: 18 YR
• Patient Sex: Male