MAUDE Adverse Event Report: TYBER MEDICAL A.L.P.S. MVX¿; 1.5MM NON-LOCKING SCREW 9MM

Model Number	770150009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was evaluated and investigated with the provided information.No images were provided and the device was discarded by the hospital staff; therefore, a device evaluation could not be performed.A device history record review was unable to be conducted as no lot-specific information was provided.A historical data analysis concluded there are no established trends or capas related to the nature of this event during the time of the investigation.No further information has been made available from the complainant.The root cause cannot be established with the provided information.
Event or Problem Description
1.5mm mvx hand plate was selected, 1st 1.5mm cortex screw was inserted into the plate.2nd screw got cortical fixation, when advancing the 1.5mm x 9mm screw the head sheared off.Opened a burr to cut around the bone to retrieve the shaft of the screw.Increase in anesthesia time for patient and extra costs added due to opening up burrs, etc to remove the retained screw shaft.

• Brand Name: A.L.P.S. MVX¿
• Common Device Name: 1.5MM NON-LOCKING SCREW 9MM
• 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: 22440808
• Report Number: 3012966183-2025-00016
• Device Sequence Number: 20010813
• Product Code: HWC
• UDI-Device Identifier: 00196449010554
• UDI-Public: 00196449010554
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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
• Device Model Number: 770150009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/08/2025
• 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: Other
• Patient Age: 31 YR
• Patient Sex: Male