A.L.P.S. MVX¿
Received May 13, 2026 · Event occurred Apr 17, 2026
Report 3012966183-2026-00005 · MDR key 25160834
Device
Product problems
- Break
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Description of Event or Problem
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.