REDAPT 71355121Recalls & reported problems
Smith & Nephew, Inc. · REDAPT REVISION ACETABULAR DRILL GUIDE · Class 2
All models of REDAPT (89)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556486597), received between Feb 14, 2021 and Jun 3, 2025 — classified as 2 malfunctions.
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
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Break; Break
IT WAS REPORTED THAT, DURING THR, THREE (3) REDAPT REV ACETABULAR DRILL GUIDE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22129749 ↗MalfunctionFeb 14, 2021Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING SURGERY, INSIDE THE PATIENT, OF THE REDAPT DRILL GUIDE. IT WAS ADVISED THAT THE DRILL GUIDE WAS FULLY SEATED WITHIN THE SCREW HOLE TO AVOID DAMAGING THE TABS ACCORDING TO SURGICAL TECHNIQUE. BUT THIS WAS FOUND TO CREATE DIFFICULTIES IN SEEING THE DRILL BIT AND KNOWING IF IT WAS FULLY SEATED IN THE BONE WITHIN THE DRILL GUIDE TO BE READY TO DRILL. WHEN HE FELT RESISTANCE HE THOUGHT THE BIT MUST BE SITTING ON THE BONE, SO HE BEGAN TO DRILL, BUT FOUND THAT IT REALLY WAS NOT AND THIS CAUSED THE BIT TO BEND WITHOUT DRILLING THE BONE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11326192 ↗
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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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