MAUDE Adverse Event Report: TYBER MEDICAL 3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 26MM; SCREWS

Model Number	04.333.226TS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review demonstrated no non-conformances or capas related to the lot as the lot met specifications.The device remains implanted and the fragments remained in the patient are from another device not made by tyber medical.
Event or Problem Description
The patient did not develop a surgical site infection.He had some delayed wound healing related to that two cchs implants were implanted, received on through (b)(4).Dr (b)(6) stated that the patient was currently happy and would see him again in 4 weeks.If revision surgery is happy, dr (b)(6) will remove drill fragment at that time.If not, he has stated that he will leave it where it is.X-ray revealed: screw has migrated slightly and drill bit fragment identified.The fragments generated are from an unknown drill device not made at tyber medical.

• Brand Name: 3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 26MM
• Common Device Name: SCREWS
• 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: 18228801
• Report Number: 3012966183-2023-00027
• Device Sequence Number: 5531688
• Product Code: HWC
• UDI-Device Identifier: 00819917027495
• UDI-Public: 00819917027495
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/29/2023

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 Expiration Date: 07/26/2026
• Device Model Number: 04.333.226TS
• Device Lot Number: 224165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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: Male