NA 03.614.039Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034715070), received between Sep 14, 2017 and May 26, 2023 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY (C1) PERFORMED ON (B)(6) 2023. WHEN THE SURGEON INSERTED A SCREW IN C1 BY THE SCREWDRIVER, THE SCREWDRIVER GOT ENGAGED IN THE SCREW. THEREFORE, THE SURGEON REMOVED THE SCREW ONCE AND EXCHANGED THE SCREWDRIVER TO ANOTHER ONE AND REINSERTED THE SCREW AGAIN. THE REINSERTED SCREW IS THE ONE THAT THE SCREWDRIVER ENGAGED IN AT FIRST. BETWEEN THE REMOVAL OF THE SCREW AND REINSERTION OF THE SCREW, THE OPERATION TIME WAS EXTENDED BY APPROXIMATELY 60 MINUTES AND 1,600 ML OF BLOOD WAS LOST, AFFECTING THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ABOUT 60 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17009206 ↗
• 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. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CROSS PINNED HEX SCREWDRIVER SHAFT/QC. THIS IS REPORT 5 OF 7 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463455 ↗
• 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 CROSS PINNED HEX SCREWDRIVER SHAFT/QC. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463431 ↗
• MalfunctionFeb 3, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, BOTH POLYAXIAL SCREWDRIVER HOLDERS WERE STRIPPED. ONE OF THE SCREWDRIVERS COLD WELDED A SCREW TO IT AND COULD NOT BE REMOVED. THIS REPORT IS FOR ONE (1) CROSS PINNED HEX SCREWDRIVER SHAFT/QC THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440281 ↗
• MalfunctionSep 9, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING SURGERY WHEN INSERTING A PEDICLE SCREW, THE SCREW DRIVER BLADE STRIPPED. A SECOND SCREWDRIVER WAS USED IN PLACE OF THE STRIPPED ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CROSS PINNED HEX SCREWDRIVER SHAFT/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448272 ↗
• MalfunctionMay 21, 2021Compatibility Problem; Compatibility Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867125 ↗
• MalfunctionApr 2, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE SCREWDRIVER WAS FAULTY. THIS REPORT IS FOR ONE (1) CROSS PINNED HEX SCREWDRIVER SHAFT/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9917810 ↗
• InjuryMar 19, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2020, TO EXTEND THE FUSION FROM L4 TO T3 AND TO REMOVE THE SYNAPSE AND USE K2MS PEDICLE SCREWS AS THE PATIENT HAD GROWN A THORACIC LUMBAR SYSTEM. TO REMOVE THE SYNAPSE PEDICLE SCREWS SURGEON USED CROSS PINNED HEX SCREWDRIVER SHAFTS. WHILE REMOVING THE SCREWS, THE HEAD OF THE ONE OF THE SCREW BROKE OFF, SO THE SURGEON USED ANOTHER CROSS PINNED HEX SCREWDRIVER SHAFT, BUT THEN THE SHAFT OF THE SCREW SHEARED IN THE PEDICLE AND THE SHAFT OF THE ANOTHER SCREW SHEARED JUST UNDER THE HEAD OF THE SCREW. CROSS PINNED HEX SCREWDRIVER SHAFTS DIDN¿T FIT THE HEAD OF THE SCREWS PERFECTLY. WHEN BEING USED TO REMOVE THE SCREWS THEY CAN STRIP AS THE HEAD OF THE SCREWS ARE STAR DRIVES AND NOT HEXAGONAL. SURGEON HAD TO CHANGE THE SURGICAL PLAN AS THE BROKEN SHAFTS WERE DIFFICULT TO REMOVE FROM THE PEDICLES. HOOKS HAD TO BE USED AT THE BOTTOM OF THE CONSTRUCT WHICH ADDED AT LEAST THIRTY (30) MINUTES TO THE OPERATION. THE CORRECTION ACHIEVED , BUT CHANCES OF LONG TERM RESULTS POSSIBLY REDUCED DUE TO HOOKS. THE BROKEN SCREW SHAFTS COULD NOT BE REMOVED AND REMAINED IN THE PATI

  Patient problems: Failure of Implant

  MAUDE report 9856021 ↗
• InjuryMar 19, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2020, TO EXTEND THE FUSION FROM L4 TO T3 AND TO REMOVE THE SYNAPSE AND USE K2MS PEDICLE SCREWS AS THE PATIENT HAD GROWN A THORACIC LUMBAR SYSTEM. TO REMOVE THE SYNAPSE PEDICLE SCREWS SURGEON USED CROSS PINNED HEX SCREWDRIVER SHAFTS. WHILE REMOVING THE SCREWS, THE HEAD OF THE ONE OF THE SCREW BROKE OFF, SO THE SURGEON USED ANOTHER CROSS PINNED HEX SCREWDRIVER SHAFT, BUT THEN THE SHAFT OF THE SCREW SHEARED IN THE PEDICLE AND THE SHAFT OF THE ANOTHER SCREW SHEARED JUST UNDER THE HEAD OF THE SCREW. CROSS PINNED HEX SCREWDRIVER SHAFTS DIDN¿T FIT THE HEAD OF THE SCREWS PERFECTLY. WHEN BEING USED TO REMOVE THE SCREWS THEY CAN STRIP AS THE HEAD OF THE SCREWS ARE STAR DRIVES AND NOT HEXAGONAL. SURGEON HAD TO CHANGE THE SURGICAL PLAN AS THE BROKEN SHAFTS WERE DIFFICULT TO REMOVE FROM THE PEDICLES. HOOKS HAD TO BE USED AT THE BOTTOM OF THE CONSTRUCT WHICH ADDED AT LEAST THIRTY (30) MINUTES TO THE OPERATION. THE CORRECTION ACHIEVED , BUT CHANCES OF LONG TERM RESULTS POSSIBLY REDUCED DUE TO HOOKS. THE BROKEN SCREW SHAFTS COULD NOT BE REMOVED AND REMAINED IN THE PATI

  Patient problems: Failure of Implant

  MAUDE report 9856010 ↗
• MalfunctionSep 14, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING FIELD INSPECTION TWO (2) HEXAGONAL SCREWDRIVER SHAFT WERE FOUND TO BE WORN AND HARD TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) CROSS PINNED HEX SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6866573 ↗
• MalfunctionSep 14, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING FIELD INSPECTION TWO (2) HEXAGONAL SCREWDRIVER SHAFT WERE FOUND TO BE WORN AND HARD TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) CROSS PINNED HEX SCREWDRIVER SHAFT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6866547 ↗