NA 207.668Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982148360), received between Apr 3, 2018 and Sep 25, 2018 — classified as 2 malfunctions.

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.

• MalfunctionSep 25, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2018, THE SURGEON WAS INSERTING THE 4.0MM CANNULATED SCREW-SHORT THREAD INTO THE CALCANEUS OVER THE GUIDE WIRE AND PROXIMAL CORTEX WAS DRILLED WITH 2.7 CANNULATED DRILL. THE CANNULATED SCREW WAS PLACED OVER THE GUIDE WIRE AND ADVANCED WITHOUT ISSUE AT APPROXIMATELY 80% OF INTENDED DEPTH. AT THIS POINT, THE SURGEON EXPERIENCE SIGNIFICANT RESISTANCE AGAINST THE ADVANCING SCREW/TORQUING SCREWDRIVER. WITH NOTICEABLY WORK REQUIRED THE SURGEON WAS ABLE TO ADVANCE THE SCREW TO ITS DESIRED DEPTH WITH NAKED EYES. A RADIOGRAPH WAS TAKEN TO CONFIRM SCREW PLACEMENT, AND THERE APPEARED TO BE AN ABNORMALITY WITH THE LAST 20% OF THE SCREW LENGTH APPEARED TO UNRAVEL LIKE RIBBON WITH WIDTH CONSISTENT WITH PITCH OF CANNULATED SCREW IN DIRECTION PERPENDICULAR TO THE INTENDED PATH. IT WAS NOTED THAT THE UNWOUND SEGMENT OF THE SCREW APPEARED INTACT WITH THE REST OF THE SCREW. THERE WAS NO DISTINCT BREAK OR DISRUPTION OF THE UNWOUND SEGMENT WITH THE REST OF THE SCREW. SURGEON WAS UNSURE OF THE CAUSE OF THE ABNORMALITY, BUT SURGEON STATED THAT IT WAS POSSIBLE THAT HE WAS HITTING CORTICAL BONE AT THE TIME HE BEGAN TO EXPERIENCE THE RESI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906342 ↗
• MalfunctionApr 3, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT SURGERY FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE. DURING THE PROCEDURE, UPON INSERTION OF THE SCREW, IT WAS NOTED THAT A PIECE OF SCREW HAD BROKEN OFF IN THE PATIENT. THE SCREW WAS REMOVED, BUT A SMALL PIECE WAS UNABLE TO BE RETRIEVED AND WAS LEFT INSIDE THE BONE. PATIENT OUTCOME WAS REPORTED AS OKAY FOLLOWING THE PROCEDURE. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW-SHORT THREAD 68MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7393157 ↗