CrossBlade 0475541000Recalls & reported problems
Stryker Corporation · Bursector 4.0 mm x 125 mm. Do Not Resterilize, Do Not Use If Package Is Damaged, Keep Dry, Keep Away From Direct Sunlight · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327502749), received between Jan 19, 2021 and May 23, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device Contaminated During Manufacture or Shipping2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Burn(s)1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS VISIBLE PRESENCE OF 2 BLACK RESIDUES/DEBRIS OF SEVERAL MM WITHIN THE PACKAGING WHICH SHOULD BE FREE OF THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080102 ↗MalfunctionNov 27, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798777 ↗MalfunctionOct 27, 2021Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12708333 ↗InjuryJan 19, 2021Break
IT WAS REPORTED THAT THE DEVICE BROKE AND BURNED THE PATIENT.
Patient problems: Burn(s)
MAUDE report 11197364 ↗
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- NA 310.21Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY29 reports
- NA 351.27Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Arthrex® AR-8500OBEArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY27 reports
- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
- Arthrex® AR-8150PX-45Arthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY15 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.