INBONE 200329102Recalls & reported problems
Wright Medical Technology, Inc. · Attachment Screw M3 Long Poly Tool · 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 00889797030731), received between Oct 14, 2024 and Oct 14, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
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.
MalfunctionOct 14, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT ATTACHMENT SCREW, LONG, M3 (200329102) BROKE INSIDE THE TIBIAL TRAY (200252904) ALMOST IMMEDIATELY ONCE THE SURGEON HAD STARTED TO ADVANCE THE POLY INSERT. BOTH THE TIBIAL TRAY AND POLY INSERT WERE DAMAGED IN THIS CASE. THEREFORE, WE HAD TO USE ANOTHER TIBIAL TRAY AND POLY IMPLANT AND RE-IMPLANT. ANOTHER ATTACHMENT SCREW USED TO IMPLANT THE POLY INSERT. TO IMPLANT A NEW TIBIAL TRAY, WE NEEDED TO REMOVE THE TALAR DOME AND TALAR STEM. WE WERE ABLE TO RE-ASSEMBLE THE TALAR DOME AND USE THE NEW IMPLANT. THIS INCIDENT CAUSED A 45 MINUTE DELAY IN THE PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITH A NEW TIBIAL TRAY AND POLY INSERT. POWER TOOLS WAS NOT USED AND NO EXTRA TORQUE WAS APPLIED BY SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20445281 ↗
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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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