NA 690.354.60Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982252852), received between Apr 16, 2019 and Dec 1, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT ON (B)(6) 2022, THE MEASURING DEVICE OF THE SCREW CADDY FOR THE 3.5/4.0 MODULE IN THE MODULAR FOOT SET WAS INCORRECT. IT WAS GIVING THE INCORRECT MEASUREMENT WHILE TRYING TO MEASURE THE 3.5/4.0 SCREWS. THIS WAS DISCOVERED PRE-OPERATIVELY, AND THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE SCREW RACK FOR MODULAR FOOT SET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892872 ↗
• MalfunctionApr 16, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE, WHILE WORKING, THE SCRUB NURSE NOTICED THAT THERE WAS AN INCORRECT MEASUREMENT OF THE SCREW LENGTHS ON THE SCREW RACK. THE NURSE DECIDED TO OPEN ALL THREE OF THE SETS CONTAINING THIS CADDY AND CONFIRMED THAT ALL THREE WERE MEASURING INCORRECTLY. ACTION TAKEN WAS MEASURED SCREW REVERSES ON THE MEASURING GUIDE AND CONFIRMED WITH THE PAPER RULER. THE PROCEDURE WAS SUCCESSFUL WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520887 ↗
• MalfunctionApr 16, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE, WHILE WORKING, THE SCRUB NURSE NOTICED THAT THERE WAS AN INCORRECT MEASUREMENT OF THE SCREW LENGTHS ON THE SCREW RACK. THE NURSE DECIDED TO OPEN ALL THREE OF THE SETS CONTAINING THIS CADDY AND CONFIRMED THAT ALL THREE WERE MEASURING INCORRECTLY. ACTION TAKEN WAS MEASURED SCREW REVERSES ON THE MEASURING GUIDE AND CONFIRMED WITH THE PAPER RULER. THE PROCEDURE WAS SUCCESSFUL WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520885 ↗
• MalfunctionApr 16, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE, WHILE WORKING, THE SCRUB NURSE NOTICED THAT THERE WAS AN INCORRECT MEASUREMENT OF THE SCREW LENGTHS ON THE SCREW RACK. THE NURSE DECIDED TO OPEN ALL THREE OF THE SETS CONTAINING THIS CADDY AND CONFIRMED THAT ALL THREE WERE MEASURING INCORRECTLY. ACTION TAKEN WAS MEASURED SCREW REVERSES ON THE MEASURING GUIDE AND CONFIRMED WITH THE PAPER RULER. THE PROCEDURE WAS SUCCESSFUL WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520635 ↗