ORTHOLOC® 16109008Recalls & reported problems
Microport Orthopedics Inc. · Class 1
Data updated Oct 18, 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 M684161090081), received between Dec 2, 2019 and Dec 2, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2019Break; Break
ALLEGEDLY , TIP OF 1/8 ADVANCE DRILL BIT BROKE OFF IN PATIENT WHILE DRILLING TIBIAL SCREW HOLES. APPROX 10MM REMAINED IN-SITU. INSTEAD OF A SCREW BEING IMPLANTED INTO THE FOURTH HOLE ON THE BIOFOAM, THE BROKEN PIECE OF THE DRILL BIT REMAINS IN PLACE. 3 SCREWS ONLY WERE IMPLANTED.
Patient problems: No Information
MAUDE report 9397504 ↗
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- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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