MAUDE Adverse Event Report: TYBER MEDICAL VOLT¿ WRIST TREATMENT SYSTEM; 2.4/2.7 2COLUMN DIST RADIUS PLATE 6HEAD/3SHFT/RIGHT/NRW/53MM

Model Number	02.426.530
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was evaluated with the available information provided in the customer's initial notification.The device was discarded; therefore, a device evaluation is unable to be performed.A review of batch records could not be completed, as no batch information was made available.Additional information was requested from the complainant, but no information was received.The root cause cannot be established with the currently available information.
Event or Problem Description
First time system user.Multiple screws would not lock into the plate.Most ulnar, 2nd most ulnar, and radial styloid screw.We tried every single locking guide, changing the trajectory of our drill, swapping to a new plate, burned 12 screws.We learned things about the plate including that the locking threads of the screw itself go past the plate.So when the plate is not sitting flush they can lock in, when it is they cannot.Also the plate has little to no tolerance for actual va drilling.You have to be perfectly aligned with the hole in order to get it to lock.Trying everything we could do make it work.Including swapping plates, screws, drill guides, drill trajectory.45 minutes surgery delayed due to the reported event.Procedure was successfully completed.No fragments generated.Suboptimal fixation on an 82yo.No other medical intervention.

• Brand Name: VOLT¿ WRIST TREATMENT SYSTEM
• Common Device Name: 2.4/2.7 2COLUMN DIST RADIUS PLATE 6HEAD/3SHFT/RIGHT/NRW/53MM
• 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: 25485849
• Report Number: 3012966183-2026-00006
• Device Sequence Number: 21411355
• Product Code: HRS
• UDI-Device Identifier: 00196449018550
• UDI-Public: 00196449018550
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K251361
• 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): 06/12/2026

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: 02.426.530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/12/2026
• 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
• Patient Age: 82 YR
• Patient Sex: Unknown