INBONE 200134SRecalls & reported problems
Wright Medical Technology, Inc. · Drill · Class 1
All models of INBONE (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889797057271), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (1 report).
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
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "REFERENCE 200134S (THE STERILE VERSION OF THE NON-STERILE BURR 200134 INCLUDED IN THE INSTRUMENT SET) APPEARS TO BE SLIGHTLY OVERSIZED AT THE DISTAL END COMPARED TO THE CANNULA IT SHOULD PASS THROUGH, REFERENCE 200166. ATTACHED IS AN EXPLANATORY VIDEO: THE FIRST BURR IS THE STERILE ONE (REF 200134S), WHICH GETS STUCK IN THE CANNULA, WHILE THE SECOND IS THE NON-STERILE BURR (REF 200134), WHICH SLIDES THROUGH THE CANNULA WITHOUT JAMMING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830183 ↗
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- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 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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