MOSS 279712600Recalls & reported problems
Depuy Spine, LLC · MOSS MIAMI SPINE SYSTEM HEXLOBE DRIVER 5.5 x25 · Class 1
Quick summary
This DePuy MOSS Miami Spine hexlobe driver is a surgical tool used with a spinal implant system. Its 704 reports, none involving deaths or injuries, mostly describe the driver being bent or twisted, deformed, or broken. Recent reports describe instruments chipping and breaking during surgery, sometimes inside the patient. No recalls name this device, and reports in the last 12 months number 21, up from 11 in the year before.
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
- 706
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 706 adverse event reports that list this exact device (DI 10705034199030), received between Jun 23, 2017 and Sep 11, 2026 — classified as 706 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (413 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
- Material Twisted/Bent413
- Material Deformation181
- Break99
- Device-Device Incompatibility31
- Mechanical Problem31
- Material Integrity Problem9
- Defective Device2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions487
- No Consequences Or Impact To Patient156
- No Known Impact Or Consequence To Patient45
- Not Applicable12
- Insufficient Information10
- Device Embedded In Tissue or Plaque4
- No Patient Involvement4
- Spinal Column Injury4
Recent adverse event reports
The 25 most recent of 706 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741428 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741399 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741206 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741195 ↗MalfunctionAug 27, 2026Break
It was reported that X25 FINAL TIGHTENER, VERSE X25 INSERTER/TIGHTENER, and FINAL TIGHTENER X20 chipped too quickly and broke during use, including reports that tips broke inside the patient. The event was identified pre-operatively/intraoperatively during use. No patient harm or significant delay was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478874 ↗MalfunctionAug 27, 2026Break
It was reported that X25 FINAL TIGHTENER, VERSE X25 INSERTER/TIGHTENER, and FINAL TIGHTENER X20 chipped too quickly and broke during use, including reports that tips broke inside the patient. The event was identified pre-operatively/intraoperatively during use. No patient harm or significant delay was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478843 ↗MalfunctionJul 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50053511 ↗MalfunctionMar 18, 2026Break; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631721 ↗MalfunctionMar 18, 2026Break; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631712 ↗MalfunctionMar 18, 2026Break; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631623 ↗MalfunctionMar 18, 2026Break; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629340 ↗MalfunctionMar 18, 2026Break; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625856 ↗MalfunctionMar 13, 2026Break; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE DRIVERS ARE STRIPPED/SNAPPED FROM USE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589130 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT THE TORQUE WRENCH AND SHAFT BROKE PRE-OP. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482654 ↗MalfunctionMar 2, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE FINAL TIGHTENING BROKE AT THE END AND NO LONGER ATTACHES PROPERLY TO THE SCREW. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482404 ↗MalfunctionMar 2, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE FINAL TIGHTENING BROKE AT THE END AND NO LONGER ATTACHES PROPERLY TO THE SCREW. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482357 ↗MalfunctionMar 2, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE FINAL TIGHTENING BROKE AT THE END AND NO LONGER ATTACHES PROPERLY TO THE SCREW. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482320 ↗MalfunctionMar 2, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE FINAL TIGHTENING BROKE AT THE END AND NO LONGER ATTACHES PROPERLY TO THE SCREW. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481973 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE DRIVER BROKE WHILE FINAL TIGHTENING. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929612 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE DRIVER BROKE WHILE FINAL TIGHTENING. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929608 ↗MalfunctionDec 18, 2025Break; Break
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. NO CONSEQUENCE FOR PATIENT. SURGERY PERFORMED AS PLANNED. ANOTHER INSTRUMENT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837446 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT TWO (2) X25 TORQUE SHAFTS HAVE BROKEN DURING REGULAR SPINAL FIXATION, 1 LEVEL SURGERY. SURGEON HAD TROUBLE GETTING THE BROKEN PARTS OUT OF THE SET SCREW. IT CAN NO LONGER BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767930 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT TWO (2) X25 TORQUE SHAFTS HAVE BROKEN DURING REGULAR SPINAL FIXATION, 1 LEVEL SURGERY. SURGEON HAD TROUBLE GETTING THE BROKEN PARTS OUT OF THE SET SCREW. IT CAN NO LONGER BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767924 ↗MalfunctionOct 27, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS DAMAGED/BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389176 ↗MalfunctionJul 25, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS BROKEN. IT WAS PRESENTED THAT WHEN USING THE TORQUE SCREWDRIVER IT IS EVIDENT THAT THIS ARRIVED WITH THE BROKEN TIP AND IT DO NOT ARRIVE PEDICLE MARKERS. THE MISSING MARKERS ARE AS IMPORTANT AS THE PUNCH OR LEZNA AND ARE ESSENTIAL IN THIS TYPE OF PROCEDURE. TO CONTINUE WITH THE PROCEDURE KIRSCHNER PINS WERE USED WHICH SUCCEEDING IN COMPLETING THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610488 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
- INHANCE 6205-10-105Depuy (Ireland) · DRIVER, PROSTHESIS191 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.