NA 2598-07-440Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS COR/TRI ANTERIOR STEM INSERT SHAFT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy hip stem inserter shaft appears in 661 adverse event reports, with no deaths and 15 injuries. Reports mostly describe the instrument breaking, with the inserter tip or handle snapping, sometimes during surgery, and some mention a foreign body in the patient. There are no recalls that 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
- 665
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 665 adverse event reports that list this exact device (DI 10603295148425), received between Jan 10, 2017 and Sep 23, 2026 — classified as 15 injuries, 650 malfunctions.
The most frequently reported specific device problem is “Break” (615 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
- Break615
- Entrapment of Device43
- No Apparent Adverse Event11
- Component Missing10
- Device-Device Incompatibility10
- Naturally Worn8
- Crack7
- Appropriate Device Problem Term/Code Not Available6
Patient problems
- No Consequences Or Impact To Patient288
- No Clinical Signs, Symptoms or Conditions248
- No Information72
- Insufficient Information26
- Not Applicable23
- Foreign Body In Patient19
- No Code Available12
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 25 most recent of 665 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874409 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874405 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874392 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718984 ↗MalfunctionAug 31, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518352 ↗MalfunctionAug 31, 2026No Apparent Adverse Event
It was reported Instruments were damaged during surgery. Surgery was delayed 10 minutes. New instruments were opened. Procedure completed successfully. No patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50517986 ↗MalfunctionAug 18, 2026Break
It was reported that tip of inserter broke off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301727 ↗MalfunctionJun 17, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE IMPACTED PRODUCT HAD AN UNKNOWN ALLEGATION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536487 ↗MalfunctionJun 2, 2026Break
IT WAS REPORTED THAT THE ANTERIOR INSERTER SHAFT BROKE. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25362627 ↗MalfunctionMay 26, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278289 ↗MalfunctionMay 5, 2026Break
IT WAS REPORTED THAT THE T- HANDLE WAS BROKEN. THE PLASTIC HAND PIECE CRACKED AND UNABLE TO BE USED. THE EVENT DID NOT HAPPEN DURING SURGERY. IT WAS REPORTED THAT THERE WERE OTHER DEVICES THAT ALSO NEEDED REPLACEMENT. THE T-HANDLE AND ANTERIOR INSERTER FROM THE CORAIL TRAYS, ALONG WITH EMPHASYS 36 LINER IMPACTOR TIP. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086021 ↗MalfunctionApr 27, 2026Device-Device Incompatibility
IT WAS REPORTED THAT CORAIL IMPACTOR HANDLE AND CURVED IMPACTION PIECE WERE STUCK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24998099 ↗MalfunctionApr 13, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE IMPACTED PRODUCT HAD AN UNKNOWN ALLEGATION. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24864647 ↗MalfunctionApr 8, 2026Break
BROKEN TIP. WHERE / WHEN DID THE EVENT OCCUR? INTRA-OP. WAS SURGERY TIME EXTENDED AS A DIRECT RESULT OF INCIDENT? NO. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT. WAS A PATIENT INVOLVED: YES THE TIP WAS MISSING FROM THE INSTRUMENT SO IT MUST HAVE BROKEN OFF INTO 2 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24822726 ↗MalfunctionApr 7, 2026Break
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE TIPS OF TWO COR/TRI ANT STEM INSERT SHAFT DEVICES BROKE OFF. SURGERY TIME WAS NOT EXTENDED AS A DIRECT RESULT OF THIS EVENT. A REPLACED WITH A SAME-LIKE PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801760 ↗MalfunctionApr 7, 2026Break
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE TIPS OF TWO COR/TRI ANT STEM INSERT SHAFT DEVICES BROKE OFF. SURGERY TIME WAS NOT EXTENDED AS A DIRECT RESULT OF THIS EVENT. A REPLACED WITH A SAME-LIKE PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801758 ↗MalfunctionMar 10, 2026Break; Entrapment of Device
ADDITIONAL INFORMATION RECEIVED STATES THAT THE BROKEN FRAGMENT HAS NOT BEEN LEFT IN THE PATIENT. THE HOSPITAL IS NO LONGER USING THE INSTRUMENT AT THE MOMENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24561141 ↗MalfunctionMar 10, 2026Break
IT WAS REPORTED THE TIP OF THE INSTRUMENT BROKE DURING SURGERY. THE BROKEN FRAGMENT ENTERED THE PATIENT AND WAS DIFFICULT TO LOCATE AND REMOVE, BUT THERE WAS NO CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559171 ↗MalfunctionMar 6, 2026Break
IT WAS REPORTED THAT A TIP OF ANTERIOR CORAIL INSERTER SNAPPED OFF DURING CASE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24533450 ↗MalfunctionFeb 11, 2026Break; Entrapment of Device
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE TIP BROKE OFF ON BOTH COR/TRI ANT STEM INSERT SHAFT DEVICES. ONE OF THE TIPS WAS MANAGED TO BE SAVED. THE SURGERY TIME WAS NOT EXTENDED AS A DIRECT RESULT OF THE INCIDENT. THE ISSUE WAS RESOLVED BY COMPLETING THE PROCEDURE USING A COMPARABLE REPLACEMENT DEVICE OF THE SAME TYPE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: Foreign Body In Patient
MAUDE report 24317153 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE TIP BROKE OFF ON BOTH COR/TRI ANT STEM INSERT SHAFT DEVICES. ONE OF THE TIPS WAS MANAGED TO BE SAVED. THE SURGERY TIME WAS NOT EXTENDED AS A DIRECT RESULT OF THE INCIDENT. THE ISSUE WAS RESOLVED BY COMPLETING THE PROCEDURE USING A COMPARABLE REPLACEMENT DEVICE OF THE SAME TYPE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316929 ↗MalfunctionFeb 11, 2026Break
CORAIL INSERTER TIP BROKEN WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, 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: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312634 ↗MalfunctionJan 29, 2026Break
TIP BROKE OFF WHERE / WHEN DID THE EVENT OCCUR? INTRA-OP WAS SURGERY TIME EXTENDED AS A DIRECT RESULT OF INCIDENT? NO WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT. WAS A PATIENT INVOLVED: YES IS LITIGATION INDICATED OR PENDING? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208759 ↗MalfunctionJan 29, 2026Break
TIP BROKE OFF. WHERE / WHEN DID THE EVENT OCCUR: INTRA-OP. WAS SURGERY TIME EXTENDED AS A DIRECT RESULT OF INCIDENT: NO. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE: WITH SAME LIKE PRODUCT. WAS A PATIENT INVOLVED: YES. IS LITIGATION INDICATED OR PENDING: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208684 ↗MalfunctionJan 20, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE HIP IT WAS OBSERVED THAT THE TIP OF THE HANDLE OF THE IMPACT STEM WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24116740 ↗
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 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
- INHANCE 6205-10-105Depuy (Ireland) · DRIVER, PROSTHESIS191 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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