Drill bit 103.25.180Recalls & reported problems
Zimmer GmbH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024298064), received between Oct 8, 2019 and Jul 25, 2024 — classified as 5 injuries, 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture9
Patient problems
- Foreign Body In Patient3
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Fracture; Fracture
IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH NCB PP SYSTEM. AFTER SEVERAL SCREWS WERE INSERTED, THE DRILL BROKE DUE TO INTERFERENCE WITH AN ALREADY INSERTED SCREW WHEN A NEW SCREW HOLE WAS BEING DRILLED. THE BROKEN DRILL TIP COULD NOT BE EXTRACTED AND REMAINED IN THE PATIENT'S BODY. REOPERATION IS NOT PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 19829006 ↗InjurySep 12, 2022Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND TWO WEEKS AGO, DURING THE IMPLANTATION OF A DISTAL FEMUR SYSTEM, THE TIP OF THE DRILL FRACTURED AND REMAINED IN THE BONE OF THE PATIENT. THE SURGEON WAS UNABLE TO REMOVE THE FRACTURED PIECE. NO ADD ISSUES OF THE PATIENT WERE REPORTED. DELAY 0-15 MINUTES.
Patient problems: Foreign Body In Patient
MAUDE report 15400098 ↗InjuryJul 6, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THE DRILL FRACTURED INSIDE THE PATIENT¿S BONE. THE PIECE COULD NOT BE REMOVED AND REMAINED INSIDE THE PATIENT. UNKNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Foreign Body In Patient
MAUDE report 14926780 ↗MalfunctionMar 31, 2021Fracture; Fracture
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11594468 ↗MalfunctionDec 15, 2020Fracture; Fracture
DURING INITIAL SURGERY THE INSTRUMENT THAT HITCHED IN THE CORTICAL PART RESULTED IN INSTRUMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11015111 ↗MalfunctionSep 17, 2020Fracture; Fracture
INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10545393 ↗InjuryAug 18, 2020Fracture; Fracture
InjuryJul 16, 2020Fracture; Fracture
INVESTIGATION RESULT IS AVAILABLE NOW.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10281438 ↗MalfunctionOct 8, 2019Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY WHILE THE SURGEON WAS DRILLING PART OF THE FEMORAL CONDYLE, THE TIP OF THE DRILL WAS FRACTURED INSIDE THE PATIENT BONE. THE FRACTURED PORTION WAS REMOVED FROM THE PATIENT. NO PIECES REMAINS INSIDE THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9165639 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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