MAUDE Adverse Event Report: TYBER MEDICAL 7.5MM TI CANN SCREW + FT - 85MM; CANNULATED COMPRESSION HEADED SCREW

Model Number	04.355.885
Medical Device Problem Codes	Material Separation (1562); Compatibility Problem (2960); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, there was hardware removal occurred.The cannulated screws were removed because they broke and patient was revised to a hemiarthroplasty.Hardware removal.Cannulated screws removed because they broke and patient was revised to a hemiarthroplasty.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown.Did the patient require revision surgery or hardware removal? yes.Was device explanted? false.Did patient require revision surgery? false.Patient status, outcome , consequences.Was other medical intervention (e.G.X-rays.Additional procedures, prescriptions, otc, revision) required: unknown.

• Brand Name: 7.5MM TI CANN SCREW + FT - 85MM
• Common Device Name: CANNULATED COMPRESSION 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 ; 8667610933
• MDR Report Key: 18970182
• Report Number: 3012966183-2024-00006
• Device Sequence Number: 6639306
• Product Code: HWC
• UDI-Device Identifier: 00810040681196
• UDI-Public: 00810040681196
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 03/25/2024

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: 04.355.885
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/25/2024
• 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