Spiral Drill 61152-100Recalls & reported problems
I.T.S. GmbH · Spiral Drill, Cannulated, D=1.5mm/D=1.0mm, L=100mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09120047301128), received between Dec 11, 2019 and May 30, 2023 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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 18, 2026.
Most reported problems
Device problems
- Fracture5
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2023Fracture; Fracture
IT WAS REPORTED THAT A CANNULATED DRILL BROKE DURING SURGERY.THERE WERE NO DELAYS IN SURGERY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017769 ↗MalfunctionMay 30, 2023Fracture; Fracture
IT WAS REPORTED THAT A CANNULATED DRILL BROKE DURING SURGERY.THERE WERE NO DELAYS IN SURGERY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017768 ↗MalfunctionFeb 3, 2023Fracture; Fracture
IT WAS REPORTED THAT A CANNULATED SPIRAL DRILL BROKE INTRAOPERATIVELY. DEVICE WAS USED TO PRE-DRILL FOR A HEADLESS COMPRESSION SCREW SCAPHOID FIXATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16289807 ↗MalfunctionMay 4, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A CANNULATED DRILL FOR THE HEADLESS COMPRESSION SCREW 2.0MM BROKE INTRA-OPERATIVELY DURING A RADIAL HEAD FIXATION.
Patient problems: Insufficient Information
MAUDE report 14275722 ↗MalfunctionMar 1, 2022Fracture; Fracture
IT WAS REPORTED THAT A CANNULATED DRILL BROKE INTRA-OPERATIVELY AT P3 BASE IN SCLEROTIC BONE. THIS IS REPORT 1/2.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13629959 ↗MalfunctionMar 1, 2022Fracture; Fracture
IT WAS REPORTED THAT A CANNULATED DRILL BROKE INTRA-OPERATIVELY AT P3 BASE IN SCLEROTIC BONE. THIS IS REPORT 2/2.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13629956 ↗MalfunctionJan 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A CANNULATED DRILL BROKE INTRAOPERATIVELY. ORIGINAL SURGERY TIME UNKOWN. NO DELAY IN SURGERY.
Patient problems: No Information
MAUDE report 9645902 ↗MalfunctionJan 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A SCREWDRIVER SHANK BROKE INTRAOPERATIVELY.
Patient problems: No Information
MAUDE report 9556852 ↗MalfunctionDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A CANNULATED DRILL BROKE INTRA-OPERATIVELY. NO DELAY IN SURGERY.
Patient problems: No Information
MAUDE report 9450365 ↗
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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