MAUDE Adverse Event Report: TYBER MEDICAL CANNULATED SCREW SYSTEM +; 7.5MM TI CANN SCREW + FT - 95MM

Model Number	04.355.895
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was investigated with the information provided.No lot information was provided; therefore a device history record review for lot-related nonconformities could not be performed.An evaluation could not be performed, as the device was not returned for evaluation.Images were provided that confirmed the event of the screw head broken off of the shaft.Without further information or the physical device for evaluation, the root cause cannot be established.Further investigations will be performed should the device be made available for return or additional information become available.
Event or Problem Description
It was reported that on (b)(6) 2026, a 7.5 css+ screw broke when inserting it into the bone.Very little resistance needed to break the head off.Surgery was delayed for 30 minutes.No patient consequences.

• Brand Name: CANNULATED SCREW SYSTEM +
• Common Device Name: 7.5MM TI CANN SCREW + FT - 95MM
• 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: 24959133
• Report Number: 3012966183-2026-00003
• Device Sequence Number: 16002274
• Product Code: HWC
• UDI-Device Identifier: 00810040681219
• UDI-Public: 00810040681219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K252901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 04.355.895
• Device Lot Number: 21182AD93
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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: Required Intervention; Other
• Patient Sex: Unknown