MAUDE Adverse Event Report: TYBER MEDICAL CANNULATED COMPRESSION HEADLESS SCREW; 2.0MM CANN DRILL BIT QC/ 145MM

Model Number	03.333.301
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was evaluated and investigated with the provided information.The device was not returned; therefore, a device evaluation was unable to be performed.A device history record review was unable to be performed as no device lot information was received.A historical data analysis was conducted that identified no trends or capas related to the nature of this complaint.The root cause cannot be determined with the information provided.Annex g code 4756 used.The impacted device term should be drill.
Event or Problem Description
It was reported that on (b)(6) 2025 while drilling through the 1st met, resident doctor mentioned that there wasn't feeling like there was much power or any advancements with the drill bit.The surgeon assumed it was due to the nature of the patient's harder than average bone as the surgeon had already gone through 3 saw blades prior to this incident.Upon pulling the drill bit out of the tissue sleeve, the resident noticed the drill bit had snapped.Upon fluoro, it was discovered that the tip of the drill bit had snapped into one large piece, and 2 smaller pieces while also damaging the drill sleeve when pulling out.The surgeon was able to remove the large piece of the drill bit but was unable to recover the 2 smaller fragments that were stuck within the bone/osteotomy site.

• Brand Name: CANNULATED COMPRESSION HEADLESS SCREW
• Common Device Name: 2.0MM CANN DRILL BIT QC/ 145MM
• 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: 22811861
• Report Number: 3012966183-2025-00019
• Device Sequence Number: 5713254
• Product Code: LXH
• UDI-Device Identifier: 00819917026566
• UDI-Public: 00819917026566
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: 03.333.301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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