5MS P06 S0021Recalls & reported problems
In2Bones USA, LLC · 5MS, T7 Driver, Solid, AO, Sterile, Single-Use · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810021861869), received between Jul 18, 2022 and Jul 18, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2022Fracture; Fracture
IT WAS REPORTED THAT DRING A PROCEDURE, A DRIVER TIP BROKE OFF INTO A LOCKING SCREW. THE SURGEON WAS UNABLE TO REMOVE THE TIP FROM THE HEAD OF THE SCREW. THE SURGEON ATTEMPTED TO REMOVE THE TIOP WITHOUT SUCCESS. A REVIEW OF THE PRODUCT DEVICE HISTORY RECORD INDICATED THERE WERE NO NON-CONFORMANCES AND THE PARTS WERE MANUFACURED TO SPECIFICATIONS. THE PRODUCT WAS DISPOSED OF AT THE HOSPITAL AND WAS NOT AVAILABLE FOR EVALUATION. THERE HAS BEEN NO PATIENT COMPLICATION REPORTED TO-DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15047451 ↗
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- 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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