NA 03.614.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034715049), received between May 9, 2018 and Sep 22, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING O-T FUSION (CERVICAL SPINE) FOR CERVICAL MYELOPATHY, THE SCREW IN QUESTION COULD NOT BE ATTACHED TO THE TWO SCREWDRIVERS IN QUESTION. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER SYNAPSE SCREWDRIVER. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES. THIS REPORT IS FOR A SLIP SLEEVE FOR THREADED HOLDING SLEEVE. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463489 ↗
• MalfunctionSep 22, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING O-T FUSION (CERVICAL SPINE) FOR CERVICAL MYELOPATHY, THE SCREW IN QUESTION COULD NOT BE ATTACHED TO THE TWO SCREWDRIVERS IN QUESTION. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER SYNAPSE SCREWDRIVER. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES. THIS REPORT IS FOR A SLIP SLEEVE FOR THREADED HOLDING SLEEVE. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463425 ↗
• MalfunctionDec 17, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, THE SCREWDRIVER SLEEVE IS NOT THREADING ONTO THE TULIP OF THE SCREW EASILY AND IS CAUSING THE TULIP TO BE STRIPPED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SLIP SLEEVE FOR THREADED HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027934 ↗
• MalfunctionSep 3, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SPINAL FUSION PROCEDURE TREATING MYELOPATHY, THE THREADS OF THE SLIP SLEEVE DID NOT PROPERLY ENGAGE WITH THE THREADS OF THE UNKNOWN SCREW. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT SLEEVE. THERE WAS NO SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SLIP SLEEVE FOR THREADED HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420865 ↗
• MalfunctionJun 17, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PCF IN THE CERVICAL SPINE TREATING CERVICAL CENTRUM FRACTURE ON (B)(6) 2021. THE SCRUB NURSE WAS NOT ABLE ATTACH THE HOLDING SLEEVE TO THE OUTER SLEEVE SMOOTHLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) OUTER SLEEVE F/HOLDING SLEEVE NO. 03.614. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018115 ↗
• MalfunctionApr 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT FOR A POSTERIOR CERVICAL SPINAL FUSION IN C1-C2 TREATING ATLANTOAXIAL SUBLUXATION ON (B)(6) 2020. THEY HAD NO ISSUE ON ASSEMBLING THE HOLDING SLEEVE, THE SLIP SLEEVE, THE SCREWDRIVER SHAFT, AND USING THE UNIT DURING THE PROCEDURE. HOWEVER, THEY WERE NOT ABLE TO DISASSEMBLE THOSE DEVICES. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991067 ↗
• MalfunctionJul 1, 2019Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019 DURING AN UNKNOWN PROCEDURE, THE HOLDING SLEEVE WITH THREAD WERE JAMMED WITH THE OUTER SLEEVE FOR HOLDING SLEEVE. A SCREWDRIVER SHAFT WAS ALSO WORN OUT AND NO MORE SCREWS COULD BE INSERTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY NOR PATIENT HARM REPORTED. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR AN OUTER SLEEVE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748906 ↗
• MalfunctionJan 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT A SCREWDRIVER ASSEMBLY WAS STUCK AND COULD NOT BE DISASSEMBLED DURING ROUTINE INSPECTION. THE DEVICES INVOLVED WERE A HEX SCREWDRIVER AND SLIP SLEEVE THAT COULD NOT BE REMOVED FROM THE HOLDING SLEEVE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SLIP SLEEVE FOR THREADED HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8278101 ↗
• MalfunctionMay 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A POSTERIOR CERVICAL SPINAL FUSION UTILIZING THE SYNAPSE SYSTEM ON (B)(6) 2018. AFTER THE HEX SCREWDRIVER SHAFT, THE THREADED HOLDING SLEEVE FOR POLYAXIAL SCREW, AND THE SLIP SLEEVE FOR THREADED HOLDING SLEEVE WERE ASSEMBLED, SURGEON ATTEMPTED TO TIGHTEN A SCREW WITH THE ASSEMBLED UNIT, BUT THE UNIT DID NOT FIT THE SCREW. SURGEON IMMEDIATELY STOPPED USING THE ASSEMBLED UNIT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. SURGEON STATED THE ISSUE MAY HAVE BEEN DUE TO CROSS-THREADING ON THE TIP OF THE HOLDING SLEEVE. THIS REPORT IS FOR ONE (1) SLIP SLEEVE FOR THREADED HOLDING SLEEVE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7499400 ↗