NA 352.311Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705034770765), received between Feb 16, 2017 and Aug 7, 2024 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE INNER DRIVER BROKE DURING SCREW EXTRACTION. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931384 ↗
• MalfunctionJul 17, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, AN EXTRACTION SCREWDRIVER SNAPPED AT THE TIP. THE SCREW WAS REMOVED USING A NORMAL SCREWDRIVER. NO CONSEQUENCE TO THE PATIENT. SURGERY WAS PROLONGED BY FIVE MINUTES. THIS REPORT IS FOR AN EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19762154 ↗
• MalfunctionJul 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE TIP OF THE INNER SHAFT OF THE VECTRA EXTRACTION SCREWDRIVER WAS BROKEN OFF DURING THE CASE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19688281 ↗
• MalfunctionAug 21, 2023Material Integrity Problem; Material Integrity Problem

  THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17587536 ↗
• MalfunctionMay 24, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON UNKNOWN DATE. AFTER SURGERY, A REMOVAL SURGERY OF 1 PLATE AND 4 SCREWS WAS PERFORMED ON MAY 10, 2023. DURING THE REMOVAL SURGERY, THE TIP OF THE SCREWDRIVER BROKE WHILE ENGAGED IN A SCREW, AND THE SCREW BECAME DIFFICULT TO REMOVE. SINCE THERE WERE NO OTHER SCREWDRIVERS, THE SCREW WAS REMOVED BY ANOTHER METHOD. THE TIP OF THE SCREWDRIVER WAS THIN AND MAY HAVE BEEN BROKEN DUE TO EXCESSIVE FORCE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ABOUT 60 MINUTES DELAY. THE PLANNED SURGICAL TIME WAS 60 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SCRDRIVER F/EXTRACT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16996933 ↗
• MalfunctionMay 1, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE TIP OF THE SCREWDRIVER BROKE WHILE INSERTING THE SCREW. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842844 ↗
• MalfunctionAug 8, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE CLEANING DEPARTMENT NOTICED A DEFECT OF THE EXTRACTION SCREWDRIVER DURING AN INSPECTION. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183781 ↗
• MalfunctionJun 1, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HUNGRY AS FOLLOWS: ON (B)(6) 2022, IT WAS REPORTED THAT DURING SURGERY THE PRODUCT BROKEN. IT WAS IMMEDIATELY REPLACED WITH A SAME-LIKE DEVICE, NO DELAY IN SURGERY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565448 ↗
• MalfunctionAug 11, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THAT THE EXTRACTION SCREWDRIVER WAS DEFECTIVE. PATIENT OUTCOME IS UNKNOWN. UPON INVESTIGATION FINDINGS, THIS COMPLAINT BECAME REPORTABLE AS A MALFUNCTION ON (B)(6) 2020. THIS REPORT INVOLVES ONE (1) EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390106 ↗
• MalfunctionJul 17, 2020Break; Break

  CONCOMITANT DEVICES REPORTED: PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); INNER SHAFT FOR EXTRACTION SCREWDRIVER SPINE (PART# 03.613.004, LOT# 613611J09, QUANTITY 1); SCREW HEAD CLEANING TOOL (PART # 324.071, LOT # 4869440, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289918 ↗
• MalfunctionFeb 14, 2020Break; Break

  UPDATED EVENT DESCRIPTION. IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AN EXTRACTION SCREWDRIVER BROKE. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714047 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT ON OCTOBER 14, 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, A VECTRA SCREWDRIVER BROKE LIVING A PIECE OF THE DRIVER INSIDE A TITANIUM VARIABLE-ANGLE SCREW. THE DRIVER BROKE WHILE INSERTING THE SCREW. THE PLATE AND THE SCREW WERE REMOVED AND REPLACED. THE SURGEON FELT LIKE THE SCREW WAS ANGLED TOO MUCH AND DECIDED TO REDIRECT THE SCREW. ONCE THE TIP BROKE OFF INSIDE THE SCREW THERE IS NO WAY TO USE THE SETS REMOVAL DRIVER. THE ENTIRE PLATE HAD TO BE BACKED OUT FOR THIS REASON. NO PIECE WAS LEFT IN THE PATIENT. A NEW PLATE AND SCREWS WERE IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTES SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS IS 1 OF 3 FOR REPORT (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9256037 ↗
• MalfunctionOct 24, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: BQ RECEIVED A SYNTHES SPINE INSTRUMENT FROM THE CUSTOMER. INNER DRIVE SHAFT TIP IS BROKEN. NO DETAILS OF EVENTS HAVE BEEN PROVIDED. 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 9235227 ↗
• MalfunctionJun 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSPECTION OF SYNTHES SPINE CERVICAL REMOVAL SET, THE EXTRACTION SCREWDRIVER WAS DISCOVERED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671731 ↗
• MalfunctionMar 13, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ADJACENT INTERVERTEBRAL DISEASE TO EXTEND THE FIXATION AREA FROM C4-4 TO C3-7. DURING SURGERY, THE TIP OF SCREWDRIVER FOR EXTRACTION BROKE WHEN THE SURGEON REMOVED THE CERVICAL SPINE SCREW FROM THE PATIENT¿S BODY. FIRST, THE SURGEON CLEANED OUT THE BONE FRAGMENT BY USING THE CLEANING INSTRUMENT FOR SCREWHEAD AND HELD THE SCREWHEAD BY USING THE HOLDING SLEEVE AND THE SCREWDRIVER FOR EXTRACTION. THEN, THE SURGEON ATTEMPTED TO REMOVE THE SCREW BY UNTIGHTENING COUNTERCLOCKWISE AND FOUND THAT THE TIP OF THE SCREWDRIVER WAS BROKEN WITH BREAKING SOUND. THEN, THE SURGEON RECOGNIZED THAT THE BROKEN FRAGMENT REMAINED IN THE SCREWHEAD. SUBSEQUENTLY, THE SURGEON CONFIRMED VIA X-RAY THAT THERE WAS NO BROKEN FRAGMENT REMAINED IN THE PATIENT¿S BODY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: CERVICAL SPINE SCREW (PART# 04.613.514S, LOT# UNKNOWN, QUANTITY 1); CLEANING INSTRUMENT FOR SCREWHEAD (PART# 324.071, LOT# UNKNOWN, QUANTITY 1) AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418723 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS FURTHER REPORTED THAT PATIENT WAS UNAFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086743 ↗
• MalfunctionOct 2, 2018Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE TIP OF THE EXTRACTION SCREWDRIVER WAS BROKEN OFF. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR AN EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7925371 ↗
• MalfunctionSep 28, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTED THAT THE TIP OF AN EXTRACTION SCREWDRIVER HAD BROKEN OFF. IT IS UNKNOWN IF THERE WAS PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR AN EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919954 ↗
• MalfunctionAug 20, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION ON (B)(6) 2018, THE TIP OF THE EXTRACTION SCREWDRIVER BROKE. THE SURGEON WAS USING THE EXTRACTION SCREWDRIVER TO FINAL TIGHTEN THE FOUR (4) VECTRA SCREWS DOWN. HE WANTED TO USE A DRIVER WITH A WIDER HANDLE TO GET A BETTER GRIP, AND THE SCREWDRIVER TIP BROKE OFF ON THE DRIVER. ALL THE FRAGMENTS WHERE EASILY RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES: VECTRA SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 4) THIS REPORT IS FOR AN EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796706 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE TIP OF AN EXTRACTION SCREWDRIVER WAS BROKEN DURING THE REMOVAL OF A VECTRA SCREW. FRAGMENT GENERATED FROM BROKEN DEVICE AND WAS RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONE (1) MINUTE SURGICAL DELAY. THE PATIENT WAS STABLE. THIS REPORT ADDRESSES THE BROKEN TIP OF AN EXTRACTION SCREWDRIVER DURING THE REMOVAL OF A VECTRA SCREW. THE REMOVAL OF VECTRA SCREW DUE TO ADJACENT LEVEL HAS BEEN CAPTURED UNDER RELATED COMPLAINT (B)(4). CONCOMITANT DEVICE REPORTED: VECTRA SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7728686 ↗
• MalfunctionJul 20, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY. DURING THE SURGERY, AN EXTRACTION SCREWDRIVER AND THE TEMPORARY FIXATION PIN BROKE. BONE WAX WAS USED WITH VECTRA REMOVAL SCREW DRIVER TO COMPLETE THE SURGERY. THERE WAS A 15 MINUTES SURGICAL DELAY. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) EXTRACTION SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7707074 ↗
• MalfunctionMar 19, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2018 THE REMOVAL SCREWDRIVER SHAFT FOR VECTRA BROKE OFF IN THE HEAD OF THE REMOVED SCREW. THERE IS NO REPORT OF PATIENT HARM OR SURGICAL DELAY. NO ADDITIONAL INFORMATION AT THIS TIME. THERE IS 1 DEVICE IN THIS COMPLAINT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7351753 ↗
• MalfunctionMar 16, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF AN EXTRACTION SCREWDRIVER BROKE OFF. ALL PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT VIA SUCTION. THERE WAS NO PATIENT HARM. THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7346379 ↗
• MalfunctionMar 6, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTED THE EXTRACTION SCREWDRIVER, WHICH IS COMPRISED OF THREE (3) COMPONENTS, HAS BROKEN THREADS ON THE CONNECTING SCREW AND THE SLOT ON THE WORKING PORTION OF THE SCREWDRIVER IS BROKEN. NO PATIENT INVOLVEMENT IS REPORTED. THIS REPORT IS FOR ONE (1) EXTRACTION SCREWDRIVER. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7318973 ↗
• InjuryDec 29, 2017Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE APICAL PORTION OF THE SCREWDRIVER BROKE OFF INSIDE THE SCREW. IT WAS NOT POSSIBLE TO EXTRACT THE SCREW. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. CONCOMITANT PRODUCT: SCREW (PART/LOT UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7154327 ↗