MICA 57SR0220Recalls & reported problems
Wright Medical Technology, Inc. · Burr · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889797067690), received between Aug 13, 2021 and Aug 19, 2022 — classified as 3 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2022Inaccurate Information; Inaccurate Information
IT IS REPORTED THAT THE WRONG SIZE BURR WAS IN THE PACKAGE. THE CUSTOMER DOES NOT KNOW WHAT SIZE WAS IN THE PACKAGE AS THEY IMMEDIATELY DISPOSED OF THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15260205 ↗MalfunctionAug 13, 2021Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON WAS PERFORMING HIS SECOND CHEVRON OSTEOTOMY FOR THE DAY WHEN THE THE 2X20MM BURR (INDICATED FOR A CHEVRON OSTEOTOMY) BROKE. HE HAD TO USED A SECOND BURR WITHOUT REMOVING THE BROKEN BURR FROM THE METATARSAL. THE SECOND BURR END UP BREAKING AS WELL. THE SURGEON WAS ABLE TO REMOVE THE TWO BROKEN BURRS FROM THE BONE BY USING A PAIR OF FORCEPS. AFTER USING AN THIRD 2X20MM BURR THE SURGERY WAS COMPLETED WITH NO ADDITIONAL COMPLICATIONS. THE SURGERY WAS DELAYED BY AN HOUR ADDITIONAL ANESTHESIA WAS REQUIRED TO COMPLETE THE SURGERY. THE SURGEON NOTED THAT THE PATIENT'S BONE WAS HARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12318425 ↗MalfunctionAug 13, 2021Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON WAS PERFORMING HIS SECOND CHEVRON OSTEOTOMY FOR THE DAY WHEN THE THE 2X20MM BURR (INDICATED FOR A CHEVRON OSTEOTOMY) BROKE. HE HAD TO USED A SECOND BURR WITHOUT REMOVING THE BROKEN BURR FROM THE METATARSAL. THE SECOND BURR END UP BREAKING AS WELL. THE SURGEON WAS ABLE TO REMOVE THE TWO BROKEN BURRS FROM THE BONE BY USING A PAIR OF FORCEPS. AFTER USING AN THIRD 2X20MM BURR THE SURGERY WAS COMPLETED WITH NO ADDITIONAL COMPLICATIONS. THE SURGERY WAS DELAYED BY AN HOUR ADDITIONAL ANESTHESIA WAS REQUIRED TO COMPLETE THE SURGERY. THE SURGEON NOTED THAT THE PATIENTS BONE WAS HARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12318422 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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