NA 309.503SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982185785), received between Nov 12, 2020 and Apr 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT OSTEOSYNTHESIS SURGERY FOR CALCANEUS WITH A VA CALCANEAL PLATE ONE YEAR AND A HALF AGO. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023, AND DURING THE SURGERY THE FOLLOWING EVENTS OCCURRED: - ONE SCREW BROKE AT THE HEAD, AND THE SHAFT PART REMAINED WITHIN THE PATIENT¿S BODY. - THE HEADS OF THREE SCREWS STUCK TO THE PLATE AND WERE DIFFICULT TO REMOVE. THE PLATE WAS SUCCESSFULLY REMOVED BUT THE EXTRACTION DRILL BIT BROKE. - THE SHAFTS OF THE THREE STUCK SCREWS COULD NOT BE REMOVED AND REMAINED IN THE PATIENT¿S BODY. IT WAS CONFIRMED VIA X-RAY THAT NO FRAGMENTS OTHER THAN THE FOUR SCREW SHAFT FRAGMENTS REMAINED WITHIN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM HIGH SPEED DRILL BIT STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16709195 ↗
• InjuryNov 12, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING DRILLING AT THE LEVEL OF THE RIGHT PROXIMAL HUMERUS, THE DRILL BROKE. A TUNGSTEN BIT FRAGMENT REMAINED IN THE PATIENT HUMERUS. AT THE END OF THE PROCEDURE, THE DRILL WAS DISCARDED. THERE WAS NO SURGICAL DELAY. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 2.5MM HIGH SPEED DRILL BIT STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10831450 ↗