MAUDE Adverse Event Report: TYBER MEDICAL 4.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 110MM

Model Number	04.334.502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No capas or non-conformances related to this part number on record.Only one complaint for this part number on record.No further information provided by the complainant with regards to this complaint event and the device was not returned for evaluation.The lot information was also not provided.Therefore, a root cause could not be determined.
Event or Problem Description
It was reported that on (b)(6) 2023, 4.5 ti cchs screw, 110mm lt was broken in the shaft during retrograde insertion for distal fibula fracture fixation.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.

• Brand Name: 4.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 110MM
• Common Device Name: SCREW
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 18301248
• Report Number: 3012966183-2023-00028
• Device Sequence Number: 7160180
• Product Code: HWC
• UDI-Device Identifier: 00819917025040
• UDI-Public: 00819917025040
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/11/2023

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: 04.334.502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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