MAUDE Adverse Event Report: TYBER MEDICAL A.L.P.S. MVX; ANTLATERAL TIB PLT 10H RT WIDE

Model Number	770714102
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for further investigation.A device history record review returned no nonconformities present within the lot that are related to the nature of the event.At the time of release the device met release criteria.Device evaluation confirmed that the affected plate slot was within specification.The noted surgical delay resulted from removing the affected device.At the time of this report, the root cause cannot be established with the provided information.
Event or Problem Description
Surgeon tried putting in screw into oblong hole towards top of the anterolateral distal tibia plate and screw head broke off fairly easily.He then put a screw in just proximal to the first and screw head passed through the plate and was stuck under plate.2-hour surgical delay noted after surgeon tried to remove broken screw and the screw under the plate.Screw was discarded and plate was retained.

• Brand Name: A.L.P.S. MVX
• Common Device Name: ANTLATERAL TIB PLT 10H RT WIDE
• 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: 21049118
• Report Number: 3012966183-2024-00025
• Device Sequence Number: 3279435
• Product Code: HRS
• UDI-Device Identifier: 00196449015900
• UDI-Public: 00196449015900
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/31/2024

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: 770714102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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