n.a. 28205GERecalls & reported problems
Karl Storz GmbH & Co. KG · Finish Barrel Burr · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551110232), received between Aug 15, 2023 and Aug 25, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. 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
- Fracture2
- Detachment of Device or Device Component1
Patient problems
- Laceration(s)2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440212 ↗InjuryAug 15, 2023Fracture; Fracture
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 28205GE (FINISH BARREL BURR). THE DISTAL HEAD BROKE DURING USE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BREAKAGE OF THE DEVICE OCCURED DURING A SURGERY ON A BONE SPUR. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. MEDICAL DIAGNOSTICAL INTERVENTION WAS REQUIRED. SURGICAL DELAY AND PROLONGATION OF SURGERY WERE BETWEEN 15 TO 60 MINUTES. ADVERSE CONSEQUENCES DUE TO FAILURE WERE LARGER INCISION, GREATER TISSUE DAMAGE, LONGER WOUND HEALING, LONGER WORK LOSS.
Patient problems: Laceration(s)
MAUDE report 17549069 ↗InjuryAug 15, 2023Fracture; Fracture
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 28205GE (FINISH BARREL BURR). THE DISTAL HEAD BROKE DURING USE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BREAKAGE OF THE DEVICE OCCURED DURING A SURGERY ON A BONE SPUR. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. MEDICAL DIAGNOSTICAL INTERVENTION WAS REQUIRED. SURGICAL DELAY AND PROLONGATION OF SURGERY WERE BETWEEN 15 TO 60 MINUTES. ADVERSE CONSEQUENCES DUE TO FAILURE WERE LARGER INCISION, GREATER TISSUE DAMAGE, LONGER WOUND HEALING, LONGER WORK LOSS.
Patient problems: Laceration(s)
MAUDE report 17549064 ↗
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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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