MAUDE Adverse Event Report: TYBER MEDICAL 2.0MM TI CANN COMPRESSION HEADLESS SCREW- LT-26MM

Model Number	04.334.026TS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
2.0 mm cchs screw broke while inserting.This happened twice during the surgery was surgery delayed due to the reported event? --> yes,.Action taken when event occurred? --> second screw inserted and the removed.Third screw inserted successfully.Was procedure successfully completed? --> yes.Were fragments generated? --> unknown.If yes, were they removed easily without additional intervention? --> no.If no, explain: --> they had to use broken screw removal device.Patient status/ outcome / consequences -->.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown.Is the patient part of a clinical study --> unknown.

• Brand Name: 2.0MM TI CANN COMPRESSION HEADLESS SCREW- LT-26MM
• Common Device Name: HEADLESS 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: 18926707
• Report Number: 3012966183-2024-00005
• Device Sequence Number: 19978485
• Product Code: HWC
• UDI-Device Identifier: 00819917027112
• UDI-Public: 00819917027112
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K192975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.334.026TS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/18/2024
• 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: Other
• Patient Sex: Unknown