Zodiac 92939Recalls & reported problems
Alphatec Spine, Inc. · HEXALOBE SET SCREW DRIVER SHAFT · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844856044357), received between Mar 7, 2017 and Dec 21, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Fracture1
- Material Torqued1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF WHILE REMOVING SCREWS. THE TIP WAS RETRIEVED AND DISCARDED AT THE HOSPITAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18373291 ↗MalfunctionDec 10, 2019Break; Fracture
THE TIP OF THE DRIVER FRACTURED AND BROKE DURING USE.
Patient problems: No Patient Involvement
MAUDE report 9444697 ↗MalfunctionJun 19, 2018Material Torqued; Material Twisted/Bent
THE HEXALOBE PART COMPLETELY TWISTED AND OVER TORQUED. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: No Information
MAUDE report 7613572 ↗MalfunctionMar 7, 2017Break
TIP OF THE DRIVER WAS FOUND BROKEN DURING ROUTINE INSPECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6385774 ↗
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.