NA 2236-31-000Recalls & reported problems
Depuy (Ireland) · DARRACH RETRACTOR SMALL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295106166), received between Jan 23, 2018 and Mar 10, 2025 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Break” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break14
- Crack2
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient8
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER REPLACEMENT ON (B)(6) 2025. THERE WAS A BROKEN DARRACH RETRACTOR. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21562541 ↗MalfunctionDec 6, 2024Break; Break
IT WAS REPORTED THAT BLACK PLASTIC DARRACH BROKE WHILE DISLOCATING A HUMERAL TRIAL. IT WAS NOTED TO HAVE BEEN ABRADED BY THE SAW. ALL PIECES WERE IDENTIFIED AND RETRIEVED. NO ADDITIONAL INFORMATION TO REPORT.
Patient problems: Insufficient Information
MAUDE report 20865778 ↗MalfunctionDec 6, 2024Break; Break
IT WAS REPORTED THAT BLACK PLASTIC DARRACH BROKE WHILE DISLOCATING A HUMERAL TRIAL. IT WAS NOTED TO HAVE BEEN ABRADED BY THE SAW. ALL PIECES WERE IDENTIFIED AND RETRIEVED. NO ADDITIONAL INFORMATION TO REPORT.
Patient problems: Insufficient Information
MAUDE report 20865749 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED THAT THE ITEM WAS BROKEN AND NEEDED TO BE REPLACED. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20853210 ↗MalfunctionDec 14, 2022Break; Break
IT WAS REPORTED THAT THE PLASTIC DARRACH RETRACTOR WAS BROKEN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15983643 ↗MalfunctionApr 28, 2022Break; Break
THE BLACK PLASTIC DARRACH BROKE WHILE RETRACTING IN THE SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14238001 ↗MalfunctionApr 27, 2022Break; Break
INSTRUMENT IS BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14218824 ↗MalfunctionNov 16, 2021Break; Break
IT WAS REPORTED THAT THE RETRACTOR WAS SNAPPED INTO 2 PIECES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12819841 ↗MalfunctionAug 25, 2020Break; Break
IT WAS REPORTED THAT WHILE REDUCING THE HIP DURING CASE, THE PLASTIC DARRACH WAS LEVERAGED UPON AND SUBSEQUENTLY BROKE. ALL PIECES WERE RECOVERED PRIOR TO CLOSING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10450689 ↗MalfunctionJun 5, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC DARRAH RETRACTOR BROKE DURING SURGERY. BROKE RIGHT BELOW THE HANDLE. 2 PIECES. DISCARDED BY OR. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10123551 ↗MalfunctionMar 10, 2020Crack; Scratched Material; Crack; Scratched Material
UPON INSPECTION, THE INSTRUMENT NOTED AS 22363100 DARRACH HAD A LOT OF CRACKS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9814036 ↗MalfunctionSep 5, 2019Break; Break
3 X REF: (B)(4) BROKE BY BENDING TOO MUCH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8964626 ↗MalfunctionSep 5, 2019Break; Break
3 X REF: 223631000 BROKE BY BENDING TO MUCH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8964624 ↗MalfunctionJul 1, 2019Break; Break
AFTER INVESTIGATION THE RETRACTOR WAS FOUND TO BE BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8750152 ↗MalfunctionAug 27, 2018Crack; Crack
OPERATING ROOM NURSES WERE SETTING UP FOR SHOULDER ARTHROPLASTY CASE WHEN THE WRAPPED DARRACH_D223631000 WAS OPENED IT WAS NOTED THERE WAS A CRACK IN THE DISTAL END OF THE INSTRUMENT. PATIENT CONSEQUENCE? NO. ACTION TAKEN FOR PROCEDURE: ANOTHER D223631000 WAS OPENED UP FOR THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7818469 ↗MalfunctionJan 23, 2018Break; Break
IT WAS REPORTED THAT THE BLACK PLASTIC DARRAH RETRACTOR BROKE. ALL PIECES RECOVERED. NO SURGICAL DELAY. NO BROKEN PIECES OF INSTRUMENTATION LEFT IN PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7211954 ↗
Other RETRACTOR devices
- Endo Paddle Retract 173046Covidien LP · RETRACTOR56 reports
- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 11303RIntegra Lifesciences Corporation · RETRACTOR1 recall0 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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