MAUDE Adverse Event Report: TYBER MEDICAL 4.5MM TI CANN SCREW + LT - 48MM

Model Number	04.354.548
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A historical data review on the part number demonstrated only one complaint for this part number.No capas or non-conformances are associated with this part number at the time of this evaluation.The root cause remains indeterminate.
Event or Problem Description
It was reported that on an unknown date, the screw broke while inserting.There was a surgical delay of 45 mins.Fragments were generated and the threads of the screw fragmented off with screw removal.45 min were spent trying to remove the threaded portion of the screw, but ultimately the surgeon had to leave the screw to not damage the bone further.The procedure was completed successfully.There were no patient consequences.This complaint involves one (1) device.

• Brand Name: 4.5MM TI CANN SCREW + LT - 48MM
• 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: 18094884
• Report Number: 3012966183-2023-00023
• Device Sequence Number: 5993088
• Product Code: HWC
• UDI-Device Identifier: 00810040635755
• UDI-Public: 00810040635755
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• 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): 11/08/2023

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: 04.354.548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 16 YR
• Patient Sex: Male