Phoenix CAT02504Recalls & reported problems
Stryker Corporation · PHOENIX DRILL BIT · Class 1
Quick summary
This Stryker Phoenix drill bit is used to drill into bone during surgery. Most of the 30 reports describe the bit tip breaking off during a procedure, sometimes leaving fragments in the patient that had to be retrieved, in one case with cartilage damage. There are 7 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07613252633242), received between Sep 19, 2018 and Aug 28, 2024 — classified as 7 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Break” (26 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break26
- Material Fragmentation4
- Device Fell1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Known Impact Or Consequence To Patient6
- Device Embedded In Tissue or Plaque5
- Insufficient Information5
- Foreign Body In Patient4
- Cartilage damage1
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DRILL BIT BROKE WHEN ENTERED INTO THE DRILL GUIDE PRIOR TO DRILLING INTO BONE. SURGEON BEGAN TO DRILL AND REALIZED THE TIP OF THE BIT WAS BROKEN. HAD TO BE REMOVED FROM THE PATIENT'S JOINT SPACE. CARTILAGE WAS DAMAGED WHILE TRYING TO RETRIEVE THE BROKEN DRILL BIT TIP.
Patient problems: Cartilage damage
MAUDE report 20091729 ↗MalfunctionMar 22, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18965196 ↗MalfunctionDec 18, 2023Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED WITH USE OF X-RAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18351471 ↗MalfunctionAug 2, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17446341 ↗MalfunctionJul 28, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17416183 ↗MalfunctionJun 21, 2023Break; Break
IT WAS REPORTED THAT THE PHOENIX DRILL TIP IS IN THE BONE. THE PIECE OF THE TIP POTENTIALLY REMAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17175422 ↗MalfunctionFeb 15, 2023Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16382286 ↗MalfunctionFeb 15, 2023Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16382282 ↗MalfunctionFeb 15, 2023Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16382280 ↗MalfunctionFeb 15, 2023Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16382279 ↗MalfunctionFeb 15, 2023Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16382270 ↗MalfunctionFeb 15, 2023Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16382170 ↗MalfunctionJan 20, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE WHICH REQUIRED AN ADDITIONAL SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16218715 ↗MalfunctionDec 6, 2022Break
IT WAS REPORTED THAT THE DISTAL END OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15929007 ↗MalfunctionDec 6, 2022Break
IT WAS REPORTED THAT THE DISTAL END OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15928941 ↗MalfunctionOct 13, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15595182 ↗MalfunctionAug 26, 2021Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12371981 ↗MalfunctionApr 6, 2021Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11625005 ↗InjurySep 14, 2020Break
IT WAS REPORTED THAT THE TIP BROKE OFF DURING THE PROCEDURE AND A PIECE REMAINED EMBEDDED IN THE BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Vessel Or Plaque, Device Embedded In
MAUDE report 10530851 ↗InjuryApr 8, 2020Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE AND REMAINS IN THE JOINT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 9939162 ↗InjuryMar 4, 2020Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9787443 ↗InjuryJan 9, 2020Break
IT WAS REPORTED THAT THE TIP BROKE AND A PIECE. REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 9570056 ↗InjuryJan 9, 2020Break
IT WAS REPORTED THAT THE TIP BROKE AND POTENTIALLY REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 9570053 ↗MalfunctionDec 17, 2019Break
IT WAS REPORTED THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9484448 ↗MalfunctionNov 18, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9338182 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.