NA 03.647.972Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034720807), received between Oct 19, 2017 and May 23, 2023 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K112068); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, A ZERO-P VA (VARIABLE ANGLE) KIT WAS SENT WITH BROKEN INSTRUMENTS. TWO INNER SHAFT REMOVAL SCREWDRIVERS HAD BROKEN TIPS. THIS REPORT IS FOR AN INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986623 ↗
• MalfunctionMay 23, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON APRIL 8, 2021, A ZERO-P VA (VARIABLE ANGLE) KIT WAS SENT WITH BROKEN INSTRUMENTS. TWO INNER SHAFT REMOVAL SCREWDRIVERS HAD BROKEN TIPS. THIS REPORT IS FOR AN INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986585 ↗
• MalfunctionFeb 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE REMOVAL SCREWDRIVER BROKE INSIDE THE SCREW HEAD ONCE THE SCREW WAS REMOVED FROM THE PATIENT. THERE WERE NO OTHER INCIDENTS REPORTED. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284945 ↗
• MalfunctionJan 11, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CONFERENCE OF THE MODULE, THE INSPECTION TEAM DETECTED THAT THE DEVICE IS DAMAGED/WORE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13232316 ↗
• MalfunctionMay 13, 2021Material 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, THREE (3) INNER SHAFT FOR REMOVAL SCREWDRIVERS WERE BROKEN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821892 ↗
• MalfunctionMay 13, 2021Material 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, THREE (3) INNER SHAFT FOR REMOVAL SCREWDRIVERS WERE BROKEN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821848 ↗
• MalfunctionMay 13, 2021Material 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, THREE (3) INNER SHAFT FOR REMOVAL SCREWDRIVERS WERE BROKEN. ONE (1) REMOVAL SCREWDRIVER WAS ALSO BROKEN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821722 ↗
• MalfunctionMar 24, 2021Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563468 ↗
• InjuryMar 9, 2021Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INNER SHAFT FOR REMOVAL SCREWDRIVER BROKE IN THE SCREW WHILE REPLACING AND CHANGING TRAJECTORY OF THE SCREW. THE SURGEON LET THE TIP IN THE SCREW INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11446039 ↗
• MalfunctionFeb 2, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORTED ON (B)(6) 2021 THAT THE TIP OF THE SCREWDRIVER SHAFT WAS FOUND BROKEN WHILE CHECKING TRAYS. THERE WERE NO PROCEDURE AND PATIENT INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267539 ↗
• InjuryNov 17, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A 2 LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) THE TIP OF THE DRIVER HAD BROKEN OFF. WHILE INSERTING THE THIRD ZERO P VA SCREW, THE TIP OF THE DRIVER HAD BROKEN OFF AND THE SCREW COULD NOT BE LOADED ON TO THE DRIVER. A SECOND DRIVER SHAFT WAS USED TO INSERT THE REMAINING TWO (2) SCREWS. THE SURGEON NOTED THAT THE TIP WOULD BE IN THE PATIENT, HOWEVER NO FRAGMENTS WERE SEEN ON THE X-RAY. CONCOMITANT DEVICES: UNK - SCREWS: ZERO-P VA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 3). THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10854207 ↗
• MalfunctionJul 23, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, DURING EVALUATION AT THE LOANER DEPARTMENT, AN INNER SHAFT REMOVAL SCREWDRIVER TIP WAS DISCOVERED BROKEN. THERE WAS NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8818192 ↗
• MalfunctionMay 30, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING TESTING AT SERVICE AND REPAIR, THE LOANER DEPARTMENT FOUND THAT THE TIP OF THE INNER SHAFT FOR REMOVAL SCREWDRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8654275 ↗
• MalfunctionNov 22, 2017Break; Break

  IT WAS REPORTED THAT BOTH THE REMOVAL SCREWDRIVER AND THE INNER SHAFT FOR THE REMOVAL SCREWDRIVER HAVE BROKEN TIPS. THE DEVICE ISSUES WERE FOUND DURING INSPECTION OF THE EVALUATION SET. THERE IS NO PATIENT INVOLVEMENT WITH THIS COMPLAINT. THIS COMPLAINT INVOLVES 3 DEVICES. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7052924 ↗
• MalfunctionNov 14, 2017Break; Break

  IT WAS REPORTED THE INNER SHAFT FOR REMOVAL SCREWDRIVER WAS FOUND TO HAVE A BROKEN TIP. ISSUE WAS DISCOVERED DURING INSPECTION OF THE SET. NO PATIENT OR SURGICAL INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7028886 ↗
• MalfunctionNov 9, 2017Break; Break

  ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: CERVICAL SPINE SCREW (PART# 04.647.834, LOT# 9722875, QUANTITY 2).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7014762 ↗
• MalfunctionOct 19, 2017Break; Break

  UPDATE: THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6962368 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112068. One submission often covers many models, so check the product and lot details in each record.

• Z-0455-2014 · Sep 30, 2013 · Terminated
  Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indica