NA 2176-10-000Recalls & reported problems
Depuy (Ireland) · MULLER RETRACTOR SMALL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Mueller retractor is a small surgical retractor used in hip surgery. The 50 reports describe the handle cracking or breaking off, sometimes in two pieces during procedures, with pieces retrieved in most cases. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295093657), received between Apr 12, 2018 and Sep 30, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Crack” (29 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
- Crack29
- Break22
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient10
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported that the white handle mueller was chipped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946862 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE MUELLER FEMORAL ELEVATOR BROKE INTO TWO PIECES ALONG THE WHITE HANDLE. ALL PIECES WERE RETRIEVED. NO DELAY OR ADVERSE EVENT WAS EXPERIENCED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159775 ↗MalfunctionApr 21, 2026Break
IT WAS REPORTED THAT DURING HIP SURGERY, DUE TO THE EXCESSIVE USE OF THIS MULLER RETRACTOR. THE DEVICE WAS INVOLVED IN 100 HIP SURGERIES. THE WHITE HANDLE WAS BROKEN FROM THE TIP. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940052 ↗MalfunctionFeb 19, 2026Break
IT WAS REPORTED THAT THE 1 MUELLER WAS BROKEN THE OTHER TWO HAVE BECOME CHIPPED IN THE WHITE HANDLE SECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385739 ↗MalfunctionFeb 19, 2026Break
IT WAS REPORTED THAT THE 1 MUELLER WAS BROKEN THE OTHER TWO HAVE BECOME CHIPPED IN THE WHITE HANDLE SECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385738 ↗MalfunctionFeb 19, 2026Break
IT WAS REPORTED THAT THE 1 MUELLER WAS BROKEN THE OTHER TWO HAVE BECOME CHIPPED IN THE WHITE HANDLE SECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385737 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, THE IMPACTED PRODUCT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316814 ↗MalfunctionFeb 2, 2026Crack
IT WAS REPORTED THE MULLER TYPE RETRACTOR HAD A CRACKED HANDLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24234849 ↗MalfunctionNov 20, 2025Break; Break
IT WAS REPORTED THAT BROKEN MULLER HANDLE. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23606810 ↗MalfunctionOct 24, 2025Crack; Crack
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. THE WHITE HANDLE WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23383618 ↗MalfunctionAug 4, 2025Crack; Crack
IT WAS REPORTED THAT THERE WAS CRACK IN HANDLE FROM OFFICE SET. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708049 ↗MalfunctionJul 24, 2025Crack; Crack
IT WAS REPORTED THAT THE DOCTOR NOTICED THE CRACK IN THE HANDLE DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22589314 ↗MalfunctionJun 13, 2025Break; Break
IT WAS REPORTED THE MULLER RETRACTOR HANDLE BROKE. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202610 ↗MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT THE MULLER RETRACTOR WAS FOUND CHIPPED AFTER GOING THROUGH THE WASHER IN SPD. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061134 ↗MalfunctionMay 19, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045874 ↗MalfunctionFeb 3, 2025Crack; Crack
IT WAS REPORTED THAT THE MULLER RETRACTOR WAS DAMAGED/HANDLE WAS CRACKED. THERE WAS NO ADVERSE CONSEQUENCES AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21297463 ↗MalfunctionJan 15, 2025Crack; Crack
IT WAS REPORTED THAT THE MUELLER HAD A CRACK IN THE HANDLE.
Patient problems: Insufficient Information
MAUDE report 21158836 ↗MalfunctionJan 15, 2025Crack; Crack
IT WAS REPORTED THAT THE MUELLER HAD A CRACK IN THE HANDLE.
Patient problems: Insufficient Information
MAUDE report 21158832 ↗MalfunctionDec 18, 2024Crack; Crack
IT WAS REPORTED THAT THERE WAS A CRACK IN THE HANDLE, WHICH WAS FOUND AFTER THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20964492 ↗MalfunctionNov 4, 2024Break; Break
IT WAS REPORTED THAT THE WHITE HANDLE WAS BROKE INTO TWO PIECES, THERE WAS NO HARM OR DELAY AS STAFF HAD A SECOND ALREADY ON THE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20600108 ↗MalfunctionSep 4, 2024Break; Break
IT WAS REPORTED THAT THE DEVICES HAD A BROKEN HANDLE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20134067 ↗MalfunctionJul 18, 2024Crack; Crack
IT WAS REPORTED THAT THE WHITE HANDLED MULLER HANDLE CRACKED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19770221 ↗MalfunctionApr 17, 2024Crack; Crack
IT WAS REPORTED THAT THE INSTRUMENTS WERE CRACKED. THERE WAS NO SURGICAL DELAY NOR ADVERSE CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124854 ↗MalfunctionFeb 28, 2024Crack; Crack
IT WAS REPORTED THAT DURING THE CASE THAT THE WHITE HANDLE OF THIS RETRACTOR HAD A CRACK IN IT, BUT RETRACTOR IS STILL IN ONE PIECE. NO DELAYS IN CASE BECAUSE OF THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18796169 ↗MalfunctionFeb 27, 2024Crack; Crack
IT WAS REPORTED THAT THE HANDLES WERE CRACKING ON RETRACTORS AND REPLACEMENTS ARE NEEDED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18792989 ↗
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
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 11303RIntegra Lifesciences Corporation · RETRACTOR1 recall0 reports
- Omni-Tract® 11445Integra 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.
How reports and recalls are matched · Editorial policy · Report an error on this page