MAUDE Adverse Event Report: TYBER MEDICAL A.L.P.S. MVX¿; 1.5MM NON-LOCKING SCREW 10MM

Model Number	770150010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was investigated and evaluated with the provided information from the complainant.A lot number was not provided; therefore, a review of lot related nonconformities could not be performed.A historical data analysis conducted for the part number returned no present trend or associated capa at the time of investigation.A device evaluation could not be conducted as the device was discarded after removal.The root cause cannot be established with the current information.
Event or Problem Description
Surgeon was using 1.5mm screws from the mvx handset and the screw head popped off of the screw during hand tightening.The screws had to be removed and the surgery was prolonged about 30-45 minutes to get the broken screw out.

• Brand Name: A.L.P.S. MVX¿
• Common Device Name: 1.5MM NON-LOCKING SCREW 10MM
• 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: 22205947
• Report Number: 3012966183-2025-00010
• Device Sequence Number: 6746673
• Product Code: HWC
• UDI-Device Identifier: 00196449010561
• UDI-Public: 00196449010561
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K232652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 770150010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/13/2025
• 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: Required Intervention; Other
• Patient Sex: Female