NA 319.701Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982190321), received between Apr 18, 2018 and Oct 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionOct 16, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A STANDARD OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR ON (B)(6) 2020, THE CANNULATED MEASURING DEVICE WAS NOT WORKING PROPERLY. WHEN THE SURGEON USED THE RULER TO MEASURE LENGTH AFTER INSERTING THE GUIDEWIRE INTO DRILL GUIDE, THE MEASUREMENT DIDN¿T COINCIDE WITH THE MEASUREMENT OF THE BONE AND GAVE A VALUE THAT WAS SHORTER THAN EXPECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER SCREW MEASURING DEVICE. THERE WAS A TWO (2) MINUTE SURGICAL DELAY REPORTED. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: WIRE GUIDE (PART # 324.174, LOT # UNKNOWN, QUANTITY 1), DRILL TIP GUIDEWIRE (PART # 310.243, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANNULATED SCREW MEASURING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10693020 ↗
• MalfunctionApr 18, 2018Break; Break

  IT WAS REPORTED THE CANNULATED SCREW MEASURING DEVICE WAS DISCOVERED TO BE BROKEN. NO PATIENT OR SURGICAL INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED SCREW MEASURING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7441697 ↗