S-ROM 53-0360Recalls & reported problems
Depuy (Ireland) · S-ROM T-HANDLE · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The S-ROM T-Handle is a surgical tool used in hip replacement procedures to help position implants. The 46 reports describe the plastic handle breaking, cracking, or bending, and parts jamming or not locking properly with other instruments such as the canal probe and drills. No deaths or injuries are reported, and most cases involved no effect on the patient. There are no recalls for 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
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295171546), received between Jul 24, 2017 and Sep 18, 2026 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (26 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
- Device-Device Incompatibility26
- Break17
- Material Deformation6
- Crack5
- Naturally Worn3
- Adverse Event Without Identified Device or Use Problem2
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient19
- Insufficient Information2
- No Code Available2
- No Information2
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829985 ↗MalfunctionSep 14, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763078 ↗MalfunctionSep 11, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740055 ↗MalfunctionApr 27, 2026Break
IT WAS REPORTED THAT THE EXCEL T-HANDLE BROKE INTO TWO PIECES ALONG THE WHITE HANDLED PORTION. THERE WAS NO DELAY OR ADVERSE EVENT WAS EXPERIENCED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003561 ↗MalfunctionOct 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TKS SURGERY WITH THE PRODUCTS IN QUESTION. WHEN SETTING UP THE PRODUCTS BEFORE THE SURGERY, IT WAS DISCOVERED THAT THE T-HANDLE AND PUNCH WERE NOT COMPATIBLE. WHEN USED DURING THE SURGERY, THEY BECAME STUCK AND COULD NOT BE REMOVED. THERE WAS NO PROBLEM DURING SURGERY, BUT THE USER COMPLAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372423 ↗MalfunctionOct 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TKS SURGERY WITH THE PRODUCTS IN QUESTION. WHEN SETTING UP THE PRODUCTS BEFORE THE SURGERY, IT WAS DISCOVERED THAT THE T-HANDLE AND PUNCH WERE NOT COMPATIBLE. WHEN USED DURING THE SURGERY, THEY BECAME STUCK AND COULD NOT BE REMOVED. THERE WAS NO PROBLEM DURING SURGERY, BUT THE USER COMPLAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372421 ↗MalfunctionSep 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT HANDLE WILL NOT LOCK OR ENGAGE WITH CANAL FINDER INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23024707 ↗MalfunctionSep 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE T-HANDLE AND CANAL PROBE WERE STUCK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23005062 ↗MalfunctionMay 6, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHILE PUTTING TRAYS TOGETHER SALES CONSULTANT NOTICED THAT THE MODULAR T HANDLE WOULD GET STUCK WHEN TRYING TO LOAD DRILLS. THERE WAS NO SURGICAL DELAY AND NO ADVERSE REACTIONS AS THIS WAS DISCOVERED AFTER THE CASE WAS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21970167 ↗MalfunctionApr 22, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT PATIENT UNDERWENT ARTHROPLASTY ON (B)(6) 2025. THE T-HANDLE HAS BENT AT THE END; THE TWO TABS HAVE SPREAD OUT AND DON'T HOLD ANYTHING LIKE IT SHOULD. NO FRAGMENTS OR BROKEN PIECES. THIS WAS NOTICED BY SPD DURING REASSEMBLY OF THE SET. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885561 ↗MalfunctionDec 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE END OF THE CORKSCREW BROKE OFF INTO THE END OF THE T-HANDLE AND WOULDN'T COME OUT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20854447 ↗MalfunctionJun 24, 2024Break; Break
IT WAS REPORTED THAT THE T HANDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593756 ↗MalfunctionJun 14, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE T HANDLE HAD A BROKEN CORKSCREW STUCK IN THE ADAPTOR.
Patient problems: Insufficient Information
MAUDE report 19536978 ↗MalfunctionJan 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
DURING A TOTAL HIP THE CANAL FINDER WOULD NOT STAY ON THE T-HANDLE. WE CONTINUED WITH THE CASE USING A BROACH FOR CANAL ENTRY. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18424736 ↗MalfunctionDec 28, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE T HANDLE WON'T HOLD CORKSCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18409714 ↗MalfunctionNov 21, 2023Break; Break
IT WAS REPORTED THAT THE CORKSCREW JOINT POINT BROKE. THE ACORN SHAPE THAT HOLDS THE T HANDLE ONTO THE CORKSCREW. T HANDLE IS DEBILITATED AND OUT OF COMMISSION. THERE WAS A SURGICAL DELAY OF 5 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18181497 ↗MalfunctionSep 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE CORKSCREW LOCKING PIECE WAS BROKEN OFF FROM STRESS INSIDE OF THE T HANDLE WHEN TRYING TO REMOVE THE FEMORAL HEAD. THE CORKSCREW WAS SCREWED INTO THE RESECTED HEAD AND WHEN THE DOCTOR TRANSFERRED OVER TO THE T HANDLE, THERE WAS AN AUDIBLE SNAP, AND LOSS OF LOCKING BETWEEN THE T HANDLE ATTACHMENT AND THE CORK SCREW. THE DOCTOR WAS ABLE TO REMOVE THE CORKSCREW BY HAND AND THE PATIENT WAS NOT AFFECTED. THE PIECE FROM THE CORKSCREW STUCK INTO THE T HANDLE IN UNRETRIEVABLE. THEREFORE, BOTH THE CORKSCREW AND T HANDLE ARE WASTED. THERE WAS A SURGICAL DELAY FOR 3 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17729273 ↗MalfunctionJul 17, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE T-HANDLE HAS TWO SMALL CRACKS AT THE CONNECTING END OF IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17334068 ↗MalfunctionFeb 7, 2023Break; Break
IT WAS REPORTED THAT T HANDLE BROKE IN THE MIDDLE OF THE HANDLE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16312706 ↗MalfunctionJan 25, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE WOULD NOT MATE AS INTENDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16244465 ↗MalfunctionJan 6, 2023Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DAMAGE COULD BE DESCRIBED AS WORN/BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16113941 ↗MalfunctionOct 11, 2022Break; Break
IT WAS REPORTED THAT THE T-HANDLE BROKE. THERE WAS NO REPORTED SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579912 ↗MalfunctionOct 1, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROKEN PIECE OF HEAD BALL REMOVER IS STUCK IN T-HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15525368 ↗MalfunctionApr 19, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A THA, THE SURGEON FOUND THAT THE REAMER WAS NOT CONNECTING TO THE SROM T-HANDLE AND THAT THE REAMER WOULD "SLIP" DISCONNECT. THERE LOOKS TO BE DAMAGE TO THE CONNECTING END OF THE T HANDLE, IN THE FORM OF A DENT. THIS IS LIKELY WHAT IS CAUSING THE SLIPPING OF THE REAMER. A SECOND INSTRUMENT TRAY WAS OPENED, AND THE T HANDLE FROM THAT SET WORKED APPROPRIATELY. THERE WAS A 1 MINUTE DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14140733 ↗MalfunctionOct 26, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED AS "REAMERS WOULD NOT DISENGAGE FROM T-HANDLE. QUICK CONNECT WOULD NOT GET STUCK IN THE OPEN POSITION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12698024 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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