NA 319.70Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982190314), received between Jan 10, 2020 and Mar 2, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 2, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT ON (B)(6) 2021, 2 CANNULATED SCREWS WERE PUT INTO A PATIENT¿S ANKLE AND WERE BE TOO LONG. WHEN TWO DEPTH GAUGES WERE COMPARED, IT WAS DETERMINED THAT THE DEPTH GAUGE IN QUESTION, WAS OFF AT LEAST 5MM. THE SCREWS WERE EXCHANGED, AND SURGERY SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THE SURGERY WAS DELAYED FOR 5 MINUTES. CONCOMITANT DEVICES REPORTED: 6.5MM CANNULATED SCREW FULLY THREADED 75MM (PART NUMBER 208.471, LOT UNKNOWN, QUANTITY 1). 6.5MM CANNULATED SCREW FULLY THREADED 80MM (PART NUMBER 208.472, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399883 ↗
• MalfunctionJan 10, 2020Incorrect Measurement; Use of Device Problem; Device-Device Incompatibility; Incorrect Measurement; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DEPTH GAUGE MEASURE TO 150MM BUT SURGEON ARE USING CANNULATED SCREWS UP TO 180MM. IT BECOMES AN ISSUE WHEN THEY USE THESE LONGER SCREWS. THE ACTUAL DEPTH GAUGE HAS TO BE EXCHANGE FOR THE DEPTH GAUGE THAT MEASURE UP TO 180MM (SAME PRODUCT NUMBER). THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9578614 ↗
• MalfunctionJan 10, 2020Incorrect Measurement; Use of Device Problem; Device-Device Incompatibility; Incorrect Measurement; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS:

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9578611 ↗