NA 207.650Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982148292), received between Jul 19, 2018 and Jul 15, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A LAPIDUS PROCEDURE. THE SURGEON ELECTED TO USED A 4.0 MM X50MM CANNULATED SCREW TO CROSS THE FUSION SIGHT ON THE DORSAL ASPECT OF THE FOOT. HE ADVANCED THE GUIDE WIRE TO THE APPROPRIATE DEPTH FROM THE FIRST METATARSAL TO THE MEDIAL CUNEIFORM, COUNTERSUNK, MEASURED, THEN INSERTED THE SCREW UNDER DRILL POWER. AS HE WAS PERFORMING THE FINAL TIGHTENING WITH THE HAND SCREWDRIVER HE TOOK A FLUOROSCOPIC IMAGE AND NOTICED THE SHAFT OF THE SCREW WAS BROKEN AT THE SMOOTH SHAFT/THREADS JUNCTION. THE SCREW WAS IN (2) SEPARATE PIECES. THE SMOOTH SHAFT AND HEAD PORTION OF THE SCREW WERE REMOVED BUT THE DISTAL THREADED PORTION OF THE SCREW WAS NOT ABLE TO BE REMOVED DUE TO RISK OF FURTHER BONE LOSS. THE SURGEON THEN PROCEEDED WITH (2) ELITE STAPLES FOR FIXATION AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A (15) MINUTE SURGICAL DELAY NOTED. FRAGMENTS WERE GENERATED BUT WERE REMOVED. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: UNK - SCREWDRIVERS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR (1) 4.0MM CANNULATED SCREW SHORT THREAD/50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12176690 ↗
• MalfunctionJul 30, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN ANGLE ANKLE FRACTURE PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, A SURGEON INSERTED A CANNULATED SCREW TO A MEDIUM MALLEOLUS OVER A K-WIRE. THE SCREW THREAD HAPPENED TO UNWIND INSIDE THE PATIENT. ALL THE DEVICES WERE RETRIEVED FROM THE PATIENT WITHOUT ANY ADDITIONAL AND MEDICAL INTERVENTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICE REPORTED: KIRSCHNER WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW SHORT THREAD/50MM. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731774 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED THAT DURING THE REVISION SUBTALAR FUSION AND HARDWARE REMOVAL ON (B)(6) 2018, A 4MM CANNULATED SCREW SHORT THREAD BROKE WHEN IT CROSSED A 6.5MM CANNULATED SCREW 32MM THREAD. THE SURGEON DECIDED TO LEAVE THE BROKEN SCREW AT THIS TIME. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICE REPORTED: 6.5MM CANNULATED SCREW 32MM THREAD 80MM (PART 208.438, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS CAPTURES THE INTRA-OPERATIVE SCREW BREAKAGE. THE NEED FOR THE REVISION PROCEDURE IS BEING CAPTURED ON RELATED COMPLAINT (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704264 ↗