Formula 0375941012Recalls & reported problems
Stryker Corporation · [Standard 12-Flute Barrel Bur, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight] · Class 1
All models of Formula (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327054750), received between Jul 9, 2018 and Nov 11, 2025 — classified as 3 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Device Contaminated During Manufacture or Shipping2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Excessive Heating1
- Insufficient Device Problem Information1
- Material Separation1
- Particulates1
Patient problems
- No Known Impact Or Consequence To Patient8
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information3
- Burn(s)1
- Burn, Thermal1
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528345 ↗MalfunctionOct 10, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE TIP WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15573035 ↗MalfunctionJun 15, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14699137 ↗MalfunctionJul 6, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12120700 ↗MalfunctionJul 6, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12120695 ↗MalfunctionFeb 4, 2021Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11278884 ↗MalfunctionJun 1, 2020Break; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE DEVICE FELL OFF DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10105165 ↗InjuryMar 4, 2020Break; Particulates; Break; Particulates
IT WAS REPORTED THAT THE DEVICE BROKE AND POTENTIALLY REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 9787452 ↗InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Excessive Heating; Excessive Heating
MalfunctionApr 18, 2019Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE STERILE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8529879 ↗InjuryMar 14, 2019Insufficient Device Problem Information
MalfunctionDec 4, 2018Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. PLEASE NOTE ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8129583 ↗MalfunctionJul 31, 2018Break
IT WAS REPORTED THAT THE TIP BROKE DURING A PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED, THE PIECES FELL OFF OUTSIDE OF THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7735626 ↗MalfunctionJul 31, 2018Break
IT WAS REPORTED THAT THE TIP BROKE DURING A PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED, THE PIECES FELL OFF OUTSIDE OF THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7735538 ↗MalfunctionJul 31, 2018Break
IT WAS REPORTED THAT THE TIP BROKE DURING A PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED, THE PIECES FELL OFF OUTSIDE OF THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7735532 ↗MalfunctionJul 30, 2018Break
IT WAS REPORTED THAT THE TIPS BROKE DURING THE PROCEDURE. THE PIECES FELL OFF OUTSIDE OF THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7733015 ↗MalfunctionJul 9, 2018Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING USE. ALL BROKEN PIECES WERE RETRIEVED AND PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7669806 ↗
Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices
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- Formula 0375544000Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL98 reports
- NA 0277096325Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL95 reports
- NA 310.25Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL91 reports
- Arthrex® AR-8400TDArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL86 reports
- NA 0277096275Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL72 reports
- Arthrex® AR-7300DSArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL70 reports
- NA 0277096277Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL69 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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