S-ROM 54-0030Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM TRIANGLE MILLER FRAME · Class 1
All models of S-ROM (92)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy S-ROM Triangle Miller Frame is a surgical instrument handle used in hip replacement surgery. Most of the 61 reports describe the handle breaking, cracking or coming apart, sometimes when the surgeon strikes it with a mallet to remove it; two reports involved injuries. There were no deaths. 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
- 61
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295173670), received between Aug 18, 2017 and Jan 15, 2026 — classified as 2 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Break” (46 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break46
- Device-Device Incompatibility5
- Crack3
- Detachment of Device or Device Component3
- Unintended Movement3
- Component Missing2
- Material Twisted/Bent2
- Physical Resistance/Sticking2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient19
- Insufficient Information4
- No Code Available3
- No Information3
- Hip Fracture1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. THE T-HANDLE WAS BROKEN AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24083102 ↗MalfunctionNov 11, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A THA SURGERY FOR OA ON HIP JOINT WITH THE INSTRUMENT IN QUESTION. BEFORE THE SURGERY, THE HANDLE WAS BROKEN AND COULD NOT BE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522903 ↗MalfunctionMar 31, 2025Break; Break
THE S ROM MILLER TRIANGLE FRAME HANDLE IS BROKEN. NOTICED DURING SALES TRAINING. THERE WAS NO PATIENT IMPACT AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21733929 ↗MalfunctionMar 4, 2025Break; Break
IT WAS REPORTED THAT SROM MILLER HANDLE IS BROKEN. THE T HANDLE BROKE OFF THE MILLER FRAME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21520727 ↗MalfunctionJan 22, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT IT BROKE INTO TWO PIECES, ALL OF WHICH WERE RETRIEVED. THERE WAS NO DELAY AND NO PATIENT CONSEQUENCES.
Patient problems: Insufficient Information
MAUDE report 21210195 ↗MalfunctionOct 15, 2024Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. THE TRIANGLE MILLING HANDLE BROKE IN TWO PIECES WHEN SURGEON IMPACTED TO REMOVE INSTRUMENT. BOTH PIECES WERE RETRIEVED. NO ADDITIONAL SURGERY TIME WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451208 ↗MalfunctionAug 9, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIANGLE MILLING FRAME HANDLE HAD DETACHED FROM THE FRAME WHEN IT WAS IMPACTED BY THE SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950264 ↗MalfunctionMay 16, 2024Break; Break
IT WAS REPORTED THAT THE CALCAR MILLING FRAME HANDLE BROKE AS A RESULT OF SURGEON IMPACTING WITH MALLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19330500 ↗MalfunctionFeb 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REAM WITH THE ANGLED REAMER THE REAMER GOT STUCK IN THE TRIANGLE MILLER, SO THE SALES REP OPENED ANOTHER SET BECAUSE HE WANTED TO BURRY THE ANGLED REAMER DOWN MORE AND THE SAME THING HAPPENED WITH THE 2ND SET HE OPENED. THE REAMERS NOW WON¿T MOVE FREELY WITHIN THE ANGLED MILLER, SO BOTH THE REAMER AND THE ANGLED MILLERS NEEDS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728569 ↗MalfunctionFeb 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REAM WITH THE ANGLED REAMER THE REAMER GOT STUCK IN THE TRIANGLE MILLER, SO THE SALES REP OPENED ANOTHER SET BECAUSE HE WANTED TO BURRY THE ANGLED REAMER DOWN MORE AND THE SAME THING HAPPENED WITH THE 2ND SET HE OPENED. THE REAMERS NOW WON¿T MOVE FREELY WITHIN THE ANGLED MILLER, SO BOTH THE REAMER AND THE ANGLED MILLERS NEEDS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728568 ↗MalfunctionNov 29, 2023Break; Break
IT WAS REPORTED THAT THE HANDLE BROKE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226876 ↗MalfunctionNov 29, 2023Break; Break
IT WAS REPORTED THAT THE HANDLE BROKE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226846 ↗MalfunctionNov 15, 2023Break; Break
IT WAS REPORTED THAT THE S-ROM*FRAME,TRIANGLE MILLER BROKE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 18140295 ↗MalfunctionAug 17, 2023Break; Break
IT WAS REPORTED THAT THE HANDLE OF TRIANGLE MILLING FRAME BROKE WHEN IMPACTED BY SURGEON. BACKUP INSTRUMENTS WERE ON HAND AND AVAILABLE. NO ADDITIONAL SURGERY TIME WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17564843 ↗MalfunctionJul 31, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED. THE SROM TRINAGULAR MILLER FRAME HAS SNAPPED AT THE TOP WHERE THERE IS A T -HANDLE. THIS IS IN 2 PARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17423667 ↗MalfunctionJul 17, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING SURGERY DUE TO VERY HARD BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17333665 ↗MalfunctionMay 25, 2023Break; Break
IT WAS REPORTED THAT THE TOP OF THE DEVICE WAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17003101 ↗MalfunctionMay 24, 2023Break; Break
IT WAS REPORTED THAT THE PART BROKE DURING THE CASE AND WAS THROWN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991499 ↗MalfunctionMay 1, 2023Crack; Unintended Movement; Crack; Unintended Movement
IT WAS REPORTED THAT THE TOP OF INSTRUMENT IS CRACKED HENCE HANDLE IS QUITE LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16844874 ↗MalfunctionFeb 24, 2023Unintended Movement; Unintended Movement
DURING SURGERY YESTERDAY, (B)(6) 2023, THE FOLLOWING SROM INSTRUMENTS WERE DAMAGED DURING THE PROCEDURE WHEN TRYING TO REMOVE THE SIZE 2 MILLER WHICH GOT STUCK IN THE PATIENT¿S FEMUR.
Patient problems: Insufficient Information
MAUDE report 16437323 ↗MalfunctionFeb 17, 2023Break; Break
IT WAS REPORTED THAT WHILE REAMING THE CALCAR, THE INSTRUMENT IN QUESTION SEEMED TO FALL APART. ALL PIECES BEING RETRIEVED. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16395533 ↗MalfunctionJan 26, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PIN IN T HANDLE OF MILLER FRAME CAME LOOSE. LOOP EXTRACTOR WON'T SCREW INTO SLAP HAMMER HANDLE BECAUSE IT WAS STRIPPED. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16247190 ↗MalfunctionDec 21, 2022Break; Break
IT WAS REPORTED THAT THE HANDLE OFF THE TRIANGLE MILLER CONE BROKE OFF. THIS RESULTED IN THREE PIECES. THE MILLER CONE, THE T-HANDLE AT THE TOP AND SMALL METAL POST. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16022400 ↗MalfunctionDec 21, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY VIA THA. IN THE SURGERY, THE TRIANGLE MILLER FRAME IN QUESTION WAS USED FOR MILLER CUT. THEN, THE TRIANGLE MILLER FRAME COULD NOT BE REMOVED. THE SURGEON REPEATEDLY TRIED TO REMOVE IT WITH A HAMMER, AND THE T-HANDLE PART OF THE TRIANGLE MILLER FRAME WAS BROKEN. HE WAS EVENTUALLY REMOVED USING A BONE FRAGMENT DRIVER, BUT IT TOOK ABOUT 20 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16021781 ↗MalfunctionDec 1, 2022Break; Break
UPON INSPECTION IN MDR AFTER REPROCESSING, DEVICE # 531500 AND DEVICE 540030 WERE DISCOVERED DAMAGED/BROKEN. PART# 531500 IS BENT AND DAMAGED. PART # 540030 IS BROKEN - T-HANDLE PORTION HAS SEPARATED FROM THE SHAFT OF THE DEVICE. THESE ITEMS ARE FROM LOANER SETS FROM DEPUY SYNTHES CANADA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15895196 ↗
Other REAMER devices
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- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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