MAUDE Adverse Event Report: TYBER MEDICAL A.L.P.S. MVX¿; 2.4MM NON-LOCKING SCREW 26MM

Model Number	770240026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: surgeon broke a screw during surgery.The plan was to remove the screw to remove the plate and then replace the screw.The screw head broke in the process.This allowed surgeon to remove the plate and keep the shaft of the screw in place as surgeon had intended.Surgeon believed that removing the screw would have created more harm than leaving it in place.Surgeon notified the patient and the family and dictated this in his progress note.From operative report: i was planning on replacing the two screws that captured the butterfly fragment.I removed the plate.Of the two interfragmentary screws, one of the screw heads broke off.It was still proving good capture of the interfragmentary segment, and i elected to leave it in place because i think the harm of removing it outweighed the harm of leaving it in.The second interfragmentary screws was removed while removing the plate and then placed back in the same position to hold the posterior butterfly fragment.What was the original intended procedure? : 1.Removal of external fixator under anesthesia.2.Intramedullary nail fixation left tibia.3.Intramedullary nail fixation left tibial shaft fracture.4.Open reduction internal fixation left trimalleolar ankle fracture.5.Open reduction internal fixation left syndesmotic injury.6.Application wound vac greater than 50 sq cm.7.Irrigation debridement open tibia fracture.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working); device malfunction - that is, the device did not do what it was supposed to do.Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not known.
Additional Manufacturer Narrative
The event was evaluated with the information provided.A device evaluation was unable to be performed as the device was unable to be returned.A review for lot related nonconformities could not be performed as no lot information was provided.A historical data analysis concluded that there are no trends or capas related to the nature of this event.The root cause cannot be determined with the information available.

• Brand Name: A.L.P.S. MVX¿
• Common Device Name: 2.4MM NON-LOCKING SCREW 26MM
• 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: 22350833
• Report Number: 3012966183-2025-00011
• Device Sequence Number: 8512653
• Product Code: HWC
• UDI-Device Identifier: 00196449013128
• UDI-Public: 00196449013128
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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: 770240026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/27/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 61 KG