N/A 3030007Recalls & reported problems
Medtronic Sofamor Danek, Inc. · DRIVER 3030007 ZEVO SCREW DRIVER · Class 1
Quick summary
This Medtronic Zevo screw driver is a hand instrument used to place screws during spinal fusion surgery. The 34 reports mostly describe the tool breaking, wearing out, or its tip deforming and becoming stuck in a screw head, and a few mention tips breaking off and being hard to retrieve; most involved no patient harm. There are 34 malfunction reports with no deaths and no injuries, and no recalls name this device. Reports fell sharply in the past 12 months, from 20 to 1.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00643169342293), received between Oct 7, 2020 and Mar 12, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (31 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.
Reports received per month
Most reported problems
Device problems
- Break31
- Material Deformation4
- Naturally Worn4
- Use of Device Problem2
- Mechanical Problem1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Device Embedded In Tissue or Plaque4
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Material Deformation
INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY PROCEDURE. IT WAS REPORTED THAT ONE DRIVER WAS BROKEN AND ANOTHER DRIVER WAS STRIPPED.THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577312 ↗MalfunctionOct 7, 2025Break; Use of Device Problem; Break; Use of Device Problem
ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE OTHER SCREWS WERE IMPLANTED PROPERLY IN TO THE PLATE WITHOUT ANY FRAGMENTS. THERE IS NO REVISION SURGERY PLANNED FOR EXTRACTION OF THE SCREWS OR THE PLATE. THE SCREW DRIVER TIP WAS HARD TO RETRIEVE SO ITS IN THE SCREW HEAD.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23231352 ↗MalfunctionOct 7, 2025Break; Use of Device Problem; Break; Use of Device Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR C4-C7 REVISION AND FIXATION. IT WAS REPORTED THAT THE TIP WAS BROKEN ON TWO DIFFERENT DRIVERS WHEN THE SCREW WAS USED IN THE NORMAL HOLE AND NOT THE SLOT HOLE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT PROCEDURE INVOLVED IN THE EVENT WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WITH CAGES AND PLATE. THERE WERE BROKEN FRAGMENTS OF DRIVER KEPT IN THE SCREW HEAD AS IT COULDN¿T BE REMOVED. THIS WAS ALSO DUE TO USER ERROR AS A 4.5MM SLOT SCREW SHOULD ONLY BE USED IN A SLOT HOLE AND NOT IN A NORMAL HOLE MADE FOR 3.5/4.0MM VA SD/ST SCREWS. THE PROCEDURE WAS LONGER BUT THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23231332 ↗MalfunctionJul 1, 2025Break; Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22369651 ↗MalfunctionJul 1, 2025Break; Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22369605 ↗MalfunctionJul 1, 2025Break; Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22369586 ↗MalfunctionApr 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21879403 ↗MalfunctionMar 9, 2025Break; Naturally Worn; Break; Naturally Worn
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21556603 ↗MalfunctionMar 6, 2025Break; Naturally Worn; Break; Naturally Worn
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21532897 ↗MalfunctionFeb 18, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21392520 ↗MalfunctionFeb 7, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL ANTERIOR FUSION SPINAL THERAPY. IT WAS REPORTED THAT THERE IS DAMAGE TO THE SCREWDRIVER TIP. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE DRIVER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21330772 ↗MalfunctionFeb 3, 2025Break; Break
INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21289948 ↗MalfunctionFeb 3, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING TWO DRIVERS USED FOR ALIF. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN DURING PREPARATION FOR CASE. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21289875 ↗MalfunctionJan 20, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS INSPECTED DURING A QUARTERLY AUDIT OF SETS. IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193176 ↗MalfunctionJan 20, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS INSPECTED DURING A QUARTERLY AUDIT OF SETS. IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193169 ↗MalfunctionJan 20, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS INSPECTED DURING A QUARTERLY AUDIT OF SETS. IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193154 ↗MalfunctionJan 20, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS INSPECTED DURING A QUARTERLY AUDIT OF SETS. IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193143 ↗MalfunctionJan 19, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT INSTRUMENTS ARE EITHER BROKEN OR WORN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187791 ↗MalfunctionDec 5, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE DRIVERS WERE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20851368 ↗MalfunctionNov 6, 2024Break; Naturally Worn; Break; Naturally Worn
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (QUALITY INSPECTOR) REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN AND INSTRUMENT WAS WORN. THERE WAS NO FURTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20619986 ↗MalfunctionNov 6, 2024Break; Naturally Worn; Break; Naturally Worn
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (QUALITY INSPECTOR) REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN AND INSTRUMENT WAS WORN. THERE WAS NO FURTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20619885 ↗MalfunctionOct 8, 2024Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE. IT WAS REPORTED THAT THE DRIVER BROKEN. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE DEVICE HAS BEEN USED NUMEROUS TIME AND ITS NOT AN INITIAL DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397113 ↗MalfunctionAug 8, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN INTO THE HEAD OF THE SCREW. FRAGMENT STAYED IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19939883 ↗MalfunctionMay 24, 2024Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREWDRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19389595 ↗MalfunctionMay 23, 2024Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19383657 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.