NA 04.614.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034738352), received between Dec 19, 2018 and Feb 5, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE 3.5MM TI CANCELLOUS POLYAXIAL SCREW'S INNER SHAFT WAS STRIPPED AND DID NOT HOLD ADEQUATELY ON THE SCREWDRIVER. THERE WAS NO REPORTED DELAY AND IT WAS UNKNOWN IF SURGERY WAS SUCCESSFUL. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671758 ↗
• MalfunctionFeb 5, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SCREWS INNER SHAFT WAS STRIPPED AND HOT HOLDING ADEQUATELY ON THE SCREWDRIVER. THERE WAS NO REPORTED DELAY AND IT WAS UNKNOWN IF SURGERY WAS SUCCESSFUL. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 02 OF 03 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671719 ↗
• MalfunctionFeb 5, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SCREWS INNER SHAFT WAS STRIPPED AND HOT HOLDING ADEQUATELY ON THE SCREWDRIVER. THERE WAS NO REPORTED DELAY AND IT WAS UNKNOWN IF SURGERY WAS SUCCESSFUL. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 01 OF 03 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671701 ↗
• MalfunctionJan 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CANCELLOUS BONE SCREW SYNAPSE DID NOT FIT ON THE SCREWDRIVER. PROCEDURE AND PATIENT INVOLVEMENT ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 3.5MM TI CANCELLOUS POLYAXIAL SCREW 16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287386 ↗
• MalfunctionDec 19, 2018Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SCRUB NURSE NOTICED A CANCELLOUS POLYAXIAL SCREW WAS STUCK/JAMMED IN ONE POSITION AND COULD NOT BE RELEASED OR LOADED. THE SURGEON USED ANOTHER SCREW WITH THE SAME TYPE TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT MEDICAL PRODUCT: UNKNOWN RODS: SYNAPSE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).  THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183167 ↗