NA 389.477Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034775838), received between Aug 5, 2020 and Oct 12, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 16, 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.

• MalfunctionOct 12, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE TAP IS NOT AS SHARP. THIS REPORT IS FOR ONE (1) TAP FOR 3.5MM CORTEX SCREWS/ 50MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10666694 ↗
• MalfunctionAug 5, 2020Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SYNAPSE TAPS WERE DISCOVERED AS NO LONGER BEING SHARP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDE SLEEVE FOR TAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN HANDLE WITH QUICK COUPLING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 TAP FOR 3.5MM CORTEX SCREWS/ 50MM CALIBRATION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10367791 ↗
• MalfunctionAug 5, 2020Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SYNAPSE TAPS WERE DISCOVERED AS NO LONGER BEING SHARP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDE SLEEVE FOR TAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN HANDLE WITH QUICK COUPLING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TAP FOR 3.5MM CORTEX SCREWS/ 50MM CALIBRATION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10367787 ↗