MAUDE Adverse Event Report: TYBER MEDICAL 5.5MM TI CANN SCREW +ST - 55MM; HEADED SCREW

Model Number	04.353.655
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event was investigated without the returned devices or device-specific lot information.A historical data review and trend analysis were performed revealing no trends related to the nature of this event.Further information was requested from the complainant, but no information became available.The affected devices were not accessible for testing.Without the affected devices, lot information, or the requested additional information, the root cause cannot be established at this time.
Event or Problem Description
It was reported that there has been a surgical site infection at the hospital involving devices that treated a tibial plateau fracture with no further information provided at this time.It was unknown if there was any patient consequences/outcome or if/what intervention was required.

• Brand Name: 5.5MM TI CANN SCREW +ST - 55MM
• Common Device Name: HEADED 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: 20698807
• Report Number: 3012966183-2024-00021
• Device Sequence Number: 6555702
• Product Code: HWC
• UDI-Device Identifier: 00810040683183
• UDI-Public: 00810040683183
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.353.655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/15/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown