Spiral Drill, D=2.5mm, L=305mm, AO Connector 61253-305Recalls & reported problems
I.T.S. GmbH · Class 1
Data updated Oct 18, 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 09120069818093), received between Jul 28, 2022 and Jul 28, 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 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2022Fracture; Fracture
PATIENT SCHEDULED TO COMPLETE A SURGICAL PROCEDURE FOR FRACTURE OF THE ANTERIOR PELVIS AND POSTERIOR ACETABULUM. DURING THE DEVELOPMENT OF THE SURGERY, THE DOCTOR REQUIRES DRILLS WITH A DIAMETER OF 2.5 MM, SHORT AND LONG, TO PERFORM THE BROCADE PROCEDURE, MEASUREMENT, AND LATER IMPLANTATION OF THE CORTICAL SCREWS WITH A DIAMETER OF 3.5MM AND PLATE FIXATION. AFTER HAVING IMPLANTED THE SECOND SCREW AND WHEN THE DOCTOR WAS PREPARING TO DRILL FOR THE IMPLANTATION OF THE THIRD SCREW, THE SPIRAL DRILL WITH A DIAMETER OF 2.5 MM, LENGTH 220 MM (REFERENCE: (B)(4)) SPLITS, LEAVING THE TIP AT BONE LEVEL WITHIN THE PATIENT. THE DOCTOR TRIES TO EXTRACT THE FRAGMENT OF THE DRILL BIT THAT IS IN THE PATIENT, BUT IT IS NOT POSSIBLE BECAUSE HE HAD A COMMINUTED FRACTURE AND IN ADDITION TO THIS HE HAS TO REPOSITION THE LOCATION OF THE SCREW TO BE IMPLANTED. THE DOCTOR CONTINUED WITH THE SURGERY, SO HE REQUIRED THE SPIRAL DRILL, DIAMETER 2.5 MM, LENGTH 305 MM (REFERENCE: (B)(4)) TO BE ABLE TO CONTINUE, BUT WHEN HE WAS DRILLING FOR THE IMPLANTATION OF THE LAST SCREW OF 12 IMPLANTED, THIS OTHER DRILL BIT ALSO BREAKS AND LIKE THE PREVIOUS ONE, THE TIP REMAINS AT THE BONE LEVEL INSIDE THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 15121470 ↗
Other Bit, Drill devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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