MAUDE Adverse Event Report: TYBER MEDICAL A.L.P.S. MVX¿; 3.0MM IM NAIL 50MM

Model Number	770300050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a screw broke inside of the canal.It was a metacarpal nail out of the mvx hand system.We had to try to remove the nail which was unsuccessful.There was more bone removal because of the broken nail.Add another hour and a half to the case.Nail had to stay in.
Additional Manufacturer Narrative
The event was evaluated and investigated with the currently available information.The impacted device remains implanted and not available for return; therefore a device evaluation was unable to be performed.A device history record review was unable to be performed for lot related nonconformities, as no identifying lot information was made available.A historical data analysis identified no trends related to the nature of this event.The root cause cannot be established with the available information.

• Brand Name: A.L.P.S. MVX¿
• Common Device Name: 3.0MM IM NAIL 50MM
• 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: 25160834
• Report Number: 3012966183-2026-00005
• Device Sequence Number: 10737720
• Product Code: HWC
• UDI-Device Identifier: 00196449011759
• UDI-Public: 00196449011759
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K253042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 770300050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/13/2026
• 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; Required Intervention
• Patient Sex: Unknown