EXPEDIUM 279722870Recalls & reported problems
Depuy Spine, LLC · EXPEDIUM SPINE SYSTEM CASTLE INNIE FINAL TIGHTENER WITH TORQUE INDICATOR · Class 1
All models of EXPEDIUM (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705034199436), received between Dec 12, 2017 and Mar 27, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THAT ONE TOOTH SNAPPED OFF THE FINAL TIGHTENED DURING USE. THE TOOTH WAS FOUND AND WE OPENED ANOTHER SCREW DRIVER. THE SAME HAPPENED AGAIN. LUCKILY A 3RD SCREW DRIVER WAS USED THAT DID NOT BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710694 ↗MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THAT ONE TOOTH SNAPPED OFF THE FINAL TIGHTENED DURING USE. THE TOOTH WAS FOUND AND WE OPENED ANOTHER SCREWDRIVER. THE SAME HAPPENED AGAIN. LUCKILY A 3RD SCREWDRIVER WAS USED THAT DID NOT BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710523 ↗MalfunctionNov 19, 2018Break; Break
PER REPORTER: I WAS IN A ADULT DEGENERATIVE SCOLIOSIS CASE YESTERDAY AFTERNOON IN WOODEND HOSPITAL ABERDEEN. ALL THE FAS SCREWS WERE PLACED (X14)T10-L5, RODS WERE INSERTED AND DURING THE FINAL TIGHTENING OF THE SET SCREWS USING THE OUTER INNIE TORQUE THE END OF THE INSTRUMENT BROKE. THE END OF THIS INSTRUMENT HAS CASTLE NUT CONNECTIONS - ALL 4 OF THE METAL EXTENSIONS SHEARED OFF. THIS ONLY DELAYED THE OPERATION BY A FEW MINUTES AND ALL PARTS OF THE BROKEN INSTRUMENT WERE REMOVED. I HAVE ATTACHED A PICTURE OF THE INSTRUMENT AND SENT IT FOR DECONTAMINATION BEFORE I RETURN ITEM. THERE APPEARED TO BE NO MISUSE OF THE INSTRUMENT AND IT LOOKED LIKE IT WAS SEATED CORRECTLY AND BEING USED CORRECTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8086125 ↗MalfunctionDec 12, 2017Break; Break
IT WAS REPORTED THAT A RATCHET AND TORQUE LIMITER BROKE INTRAOPERATIVELY. IN ADDITION THE TIP OF THE SCREWDRIVER DEFORMED. RATCHET: 286710490 ¿ WHEN SCREWING BROKEN THE SCREW SCREWDRIVER: 279734000 ¿ THROUGH FREQUENT USE TURN AROUND THE NECK OF THE SCREW (THE TIP OF THE SCREWDRIVER DEFORMED. ) TORQUE LIMITER: 279722870 ¿ DURING THE FINAL TIGHTENING OF THE EXTERNAL THREAD OF THE DI INNIES, ONE OF THE 3 ATTACHMENT POINTS IS BROKEN OFF. NO PATIENT HARM NOR SURGERY PROLONGATION REPORTED. PROCEDURE FINISHED SUCCESSFULLY WITH THIS COMPLAINT INVOLVES 3 PARTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7109602 ↗
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
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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