NA 2000-02-302Recalls & reported problems
Depuy (Ireland) · HEAD IMPACTOR TIP · Class 1
Quick summary
This DePuy head impactor tip is an impactor tip used in surgery. The 103 reports describe the tip breaking or cracking during procedures, sometimes shattering into pieces, with no deaths and no injuries. No recalls name this device. Reports rose from 31 to 70 over the latest 12-month period.
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
- 104
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10603295525875), received between Feb 13, 2023 and Sep 30, 2026 — classified as 104 malfunctions.
The most frequently reported specific device problem is “Break” (99 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break99
- Crack5
- No Apparent Adverse Event4
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions100
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported that upon inspection, it was observed that the Head Impactor Tip was broken in two pieces. There was no patient or user harm. There was no significant delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945834 ↗MalfunctionSep 24, 2026Break
It was reported that the black impactor tip broke in half.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882247 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542472 ↗MalfunctionJun 22, 2026Break
IT WAS REPORTED THAT THE HEAD IMPACTORS SHATTERED SENDING BLACK PIECES EVERYWHERE. THE ISSUE WAS OBSERVED DURING SURGERY THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578750 ↗MalfunctionJun 5, 2026Break; Crack
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DEVICE CRACKED AND BROKE INTO 2 PIECES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25409825 ↗MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT THE DEVICE WAS FOUND BY THE STERILE PROCESSING DEPARTMENT (SPD) TO BE BROKEN IN THE EMPHASYS OFFSET TRAY. THE EVENT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337377 ↗MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DEVICE BROKE INTO TWO PIECES. ALL PIECES RECOVERED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25336556 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT THE DEVICE BROKE INTO PIECES-ARE BREAKING AT A PRETTY HIGH CLIP THE ISSUE WAS OBSERVED DURING SURGERY THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25214985 ↗MalfunctionMay 14, 2026Break
IT WAS REPORTED THAT THE KINCISE 2 HEAD IMPACTOR TIP CRACKED INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175758 ↗MalfunctionMay 14, 2026Break
IT WAS REPORTED THAT THE HEAD IMPACTOR TIP BROKE AFTER IMPLANTATION. ALL PIECES WERE RECOVERED. THERE WERE NO DELAYS. THERE WAS NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175532 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR BLACK TIP WAS COMPLETELY BROKEN IN TWO PIECES AND REQUIRED A REPLACEMENT TIP. THE ISSUE WAS OBSERVED DURING POST-SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095279 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT THE K2 BLACK HEAD IMPACTOR TIP BROKE OFF RIGHT WHERE THE LOT NUMBER WAS SUPPOSED TO BE, SO THE LOT NUMBER WAS UNKNOWN. THE EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059526 ↗MalfunctionApr 29, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DPS HD IMP TIP BROKE INTO 2 PIECES. IT WAS REPORTED THAT ALL PIECES WERE RECOVERED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036017 ↗MalfunctionApr 29, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEAD IMPACTOR TIP BROKE WHILE IMPACTING THE FEMORAL HEAD. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028645 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT THE HEAD IMPACTOR DEVICE BROKE WHILE IMPACTING THE HEAD. THE BROKEN PIECES OF THE IMPACTOR HAVE BEEN RE-PROCESSED. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, NO DELAY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958346 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE HEAD IMPACTOR TIP BROKE DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925828 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEAD IMPACTOR TIP BROKE INTO 2 PIECES. IT WAS REPORTED THAT ALL PIECES RECOVERED. THERE WAS NO PATIENT INJURY OR DELAY TO PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889623 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT THE K2 HEAD IMPACTOR BROKE AND THE PINNACLE DRILL BIT WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24850642 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT THE HEAD IMPACTOR TIP BROKE IN HALF DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844948 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT THE HEAD IMPACTOR TIP WAS BROKEN INTO PIECES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24841405 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT THE HEAD IMPACTOR TIP, BROKE INTO 2 PIECES, ALL PIECES RECOVERED. THE ISSUE WAS OBSERVED DURING SURGERY THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754831 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE IN HALF AND NEEDS TO BE PLACED. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749545 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE ON IMPACTION. ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749451 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT THE IMPACTOR TIP WAS BROKEN APART AND NEEDS REPLACED. ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749209 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEAD IMPACTOR TIP BROKE INTO THREE PIECES. IT WAS REPORTED THAT THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. NO FRAGMENTS WERE GENERATED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24740865 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.