NA 2360-205-27Recalls & reported problems
Zimmer, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024061118), received between Apr 10, 2020 and May 20, 2026 — classified as 4 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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.
Reports received per month
Most reported problems
Device problems
- Fracture9
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient4
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Fracture
IT WAS REPORTED THAT DURING SURGERY, A DRILL BIT CONTACTED AN ALREADY INSERTED SCREW, CAUSING THE TIP OF THE DRILL TO FRACTURE AND REMAIN IN THE PATIENT¿S BODY. INTRA-OPERATIVELY, THE FRAGMENT COULD NOT BE RETRIEVED, AND THE SURGEON ELECTED TO LEAVE IT IN SITU. NO PROCEDURE TO REMOVE THE RETAINED FRAGMENT WAS PLANNED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 25234572 ↗InjuryApr 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 21861781 ↗MalfunctionJan 22, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18551487 ↗MalfunctionAug 21, 2023Fracture; Fracture
IT WAS REPORTED THAT A DRILL FRACTURED DURING SURGERY. ALL FRACTURED PIECES WERE REMOVED FROM THE PATIENT AND NOTHING WAS RETAINED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17585134 ↗MalfunctionFeb 3, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16293680 ↗MalfunctionNov 9, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DRILL BROKE DURING DRILLING, WITH NO EFFECT ON PATIENT OR USER. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15763520 ↗InjuryJul 11, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE CUTTER BROKE DURING USE AND A PORTION REMAINS INSIDE THE PATIENT'S BODY. NO REPORTED PATIENT CONSEQUENCES RESULTED FROM THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 14978617 ↗MalfunctionNov 3, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12746983 ↗InjuryApr 10, 2020Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 9947938 ↗
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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