NA 2598-07-430Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS STD STRAIGHT STEM INSERT SHAFT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295148401), received between Dec 29, 2017 and Sep 15, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Appropriate Device Problem Term/Code Not Available6
- Entrapment of Device2
- Material Deformation2
- Device Issue1
- Device-Device Incompatibility1
- Material Twisted/Bent1
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient12
- No Clinical Signs, Symptoms or Conditions9
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779003 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT THE IMPACTOR WAS BROKEN WHEN IMPACTING THE STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25091795 ↗MalfunctionDec 3, 2025Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE INSERTER AND HANDLE BROKE UPON IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706489 ↗MalfunctionJul 16, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT IS WORN AND TILTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22520392 ↗MalfunctionFeb 19, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE TIP OF THE STEM INSERTER BROKE OFF INTO THE INSERTION HOLE IN THE STEM AND REMAINED INSIDE THE PATIENT. THE PIECE WAS LATER SEEN ON POST OP X-RAY AND IS CURRENTLY STILL LODGED IN THE INSERTION HOLE BASED ON THE LATEST X-RAY SEEN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PIECE SEEN ON POSTOP X-RAY IS STILL CURRENTLY IN PLACE. ACTION PLAN HAS NOT BEEN DETERMINED.
Patient problems: Foreign Body In Patient
MAUDE report 21412552 ↗MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED THE TIP OF THE INSERTER SNAPPED OFF. IT IS UNKNOWN IF THE ISSUE WAS DISCOVERED IN STERILE PROCESSING OR FIELD INSPECTION, BUT IT WAS INDICATED THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20819417 ↗MalfunctionNov 13, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSERTER SHAFT BENT WHILE PULLING OUT CORAIL STEM. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20676053 ↗MalfunctionSep 18, 2024Break; Break
IT WAS REPORTED THAT THE INSERTER TIP BROKEN PRIOR TO SURGERY START.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20247439 ↗MalfunctionApr 11, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF IMPACTOR BROKE OFF IN STEM DURING STEM IMPACTION. IT WAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16713701 ↗MalfunctionJan 20, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF INSERTER BROKE OFF IN STEM DURING IMPLANTATION. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216681 ↗MalfunctionJul 27, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE CONNECTION BETWEEN STEM INSERTER HANDLE AND STRAIGHT STEM INSERTER SHAFT IS WORN SO THE TWO WILL NOT COMPLETELY LOCK TOGETHER. THE TAB ASPECT OF THE MODULAR BOX OSTEOTOME THAT ATTACHES TO THE BROACH HANDLE IS BENT SO IT WILL NOT FULLY SEAT ON THE BROACH HANDLE. THIS ITEMS WERE NOT USED IN A CASE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12227991 ↗MalfunctionFeb 10, 2020Break; Break
TIP OF CORAIL STEM IMPACTOR BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9689699 ↗MalfunctionDec 9, 2019Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT DURING IMPACTION OF THE CORAIL STEM, THE IMPACTOR TIP BROKE COMING OFF INSIDE THE STEM. SURGEON WAS INFORMED THAT THE TIP WAS BROKEN AND MISSING. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN IMPACTOR TIP FROM INSIDE THE STEM AFTER SEVERAL ATTEMPTS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9439545 ↗MalfunctionMay 6, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking
IT WAS REPORTED THAT THE ISSUE WITH STEM INSERTER WAS GOING TOGETHER. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8583286 ↗MalfunctionSep 14, 2018Break; Break
TIP OF IMPACTOR SHEAR OFF FROM THE END OF INSTRUMENT. MOST PROBABLY DUE TO FATIGUE FAILURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7878073 ↗MalfunctionAug 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE STRAIGHT SHAFT AND STEM HANDLE WOULD NOT ASSEMBLE WHEN CHECKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7817900 ↗MalfunctionJun 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DEPUY SYNTHES LOANER KIT OPERATOR PERFORMED A FUNCTIONAL TESTING OF DEVICES. DURING TESTING IT WAS NOT POSSIBLE TO DISASSEMBLE TWO INSTRUMENTS. NO PATIENT INVOLVEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7595952 ↗MalfunctionApr 19, 2018Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE INSERTER TIP TO HANDLE GOT STUCK. INSERTER WAS REMOVED FROM SURGICAL FIELD. BEING RETURNED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7442897 ↗MalfunctionJan 4, 2018Device Issue; Device Issue
THE STRAIGHT STEM INTRODUCER WAS VERY DIFFICULT TO REMOVE FROM THE IMPLANT AFTER INTRODUCING THE STEM IMPLANT INTO THE CANAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7163486 ↗MalfunctionDec 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE STRAIGHT STEM INTRODUCER WAS VERY DIFFICULT TO REMOVE FROM THE IMPLANT AFTER INTRODUCING THE STEM IMPLANT INTO THE CANAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7154073 ↗MalfunctionDec 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE STRAIGHT STEM INTRODUCER WAS VERY DIFFICULT TO REMOVE FROM THE IMPLANT AFTER INTRODUCING THE STEM IMPLANT INTO THE CANAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7154062 ↗MalfunctionDec 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE STRAIGHT STEM INTRODUCER WAS VERY DIFFICULT TO REMOVE FROM THE IMPLANT AFTER INTRODUCING THE STEM IMPLANT INTO THE CANAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7154054 ↗MalfunctionDec 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE STRAIGHT STEM INTRODUCER WAS VERY DIFFICULT TO REMOVE FROM THE IMPLANT AFTER INTRODUCING THE STEM IMPLANT INTO THE CANAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7154040 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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