SPECIALIST 2581-11-000Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 TIBIAL RADEL IMPACTOR · Class 1
All models of SPECIALIST (80)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist 2 tibial impactor is a surgical tool used during knee replacement surgery. Its 703 reports, with 1 injury and no deaths, mostly describe the impactor breaking or cracking. Recent reports describe impactors breaking into pieces during procedures, and some caused surgical delays. No recalls name this device, and reports in the last 12 months number 2, down from 5 in the year before.
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
- 704
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 704 adverse event reports that list this exact device (DI 10603295147916), received between Jun 30, 2017 and Sep 18, 2026 — classified as 1 injury, 703 malfunctions.
The most frequently reported specific device problem is “Break” (572 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
- Break572
- Crack91
- Device-Device Incompatibility36
- Material Integrity Problem33
- No Apparent Adverse Event31
- Naturally Worn29
- Material Twisted/Bent14
- Fracture6
Patient problems
- No Consequences Or Impact To Patient327
- No Clinical Signs, Symptoms or Conditions304
- No Information47
- Insufficient Information23
- No Code Available9
- Not Applicable8
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 704 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 50828408 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE THE SP2 TIBIAL IMPACTED BROKE INTO 2 PIECES AND THE ATTUNE FEMORAL IMPACTOR BROKE AND DEVELOPED A LARGE CRACK DURING FEMORAL IMPACTING. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. ALL PIECES WHERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161884 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT THE WHITE IMPACTOR WAS SPLIT AND BROKEN DURING THE IMPLANT PHASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513286 ↗MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT WHILE IMPACTING THE INSERT IT BROKE THE WHITE IMPACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22793437 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE DEFINITIVE WARM TRAY IMPACTOR BROKE INTO TWO PIECES DURING THE PROCEDURE. THERE WAS NO DISCOMFORT IN THE SPECIALIST. SURGERY ENDS SUCCESSFULLY. NO PATIENT CONSEQUENCE, NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21307371 ↗MalfunctionNov 20, 2024Break; Break
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THERE WAS BREAKDOWN OF THE ITEM, WHICH CAUSED A 30-MINUTE DELAY IN THE OPERATION. THE OPERATION WAS COMPLETED SUCCESSFULLY, AND NO ADDITIONAL SURGERY WAS REQUIRED DUE TO THE FAILURE.
Patient problems: Insufficient Information
MAUDE report 20733896 ↗MalfunctionNov 13, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A SURGERY ON THE RIGHT LEG VIA TKA. THE IMPACTOR GOT DAMAGED WHILE THE SURGEON WAS DRIVING AN IMPLANT INTO THE TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE SP2 TIBIAL RADEL IMPACTOR TOP SECTION WAS FOUND BROKEN.
Patient problems: Insufficient Information
MAUDE report 20675217 ↗MalfunctionNov 6, 2024Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN USING THE TIBIA IMPACTOR, IT BROKE AT THE TIME OF IMPACT. THERE WAS A FIFTEEN MINUTES DELAY IN THE SURGICAL PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY BECAUSE IT WAS FINISHED WITH OSTEOTOME. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20616096 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024, THE TIBIA IMPACTOR BROKE WHILE IMPACTING THE IMPLANT. IT BROKE INTO TWO PIECES AND ALL WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20407133 ↗MalfunctionOct 7, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT NEEDED TO BE REPLACED DUE TO BREAKDOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20383272 ↗MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE. DISCOVERED WHILE INSPECTING THE TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20286617 ↗MalfunctionSep 23, 2024Break; Break
THE IMPACTOR IS BROKEN INTO TWO. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20283873 ↗MalfunctionSep 16, 2024Break; Crack; Break; Crack
ADDITIONAL INFORMATION WAS RECEIVED: B. IS THERE ANY PATIENT HARM? NO. C. IS THERE ANY SURGICAL DELAY? NO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20223856 ↗MalfunctionJul 26, 2024Break; Break
IT WAS REPORTED THAT THE PATELLA TRIAL HAS A GOUGE IN IT THE TIBIAL IMPACTOR HAS SPLIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19836552 ↗MalfunctionJul 24, 2024Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO DELAY AND THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE REPORTED REFERENCE IS IN THE EQUIPMENT THAT READY TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817989 ↗MalfunctionJul 5, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: A. WHICH PART OF THE INSTRUMENT WAS BROKEN? THE MIDDLE. B. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, STRIPPED, WORN, OR CROSS-THREADED? TWO PIECES . C. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19681023 ↗MalfunctionJun 24, 2024Break; Break
THE TIBIAL TRAY IMPACTOR BROKE INTO TWO FRAGMENTS DURING SURGERY, THE FRAGMENTS WERE REMOVED AND ANOTHER IMPACTOR WAS USED. THE SURGERY WAS FINISHED SUCCESSFULLY, WITHOUT DELAYS OR CHANGES IN SURGICAL TIMES OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593326 ↗MalfunctionMay 6, 2024Break; Break
THE INSTRUMENT WAS BROKEN DURING A TOTAL KNEE REPLACEMENT. THE SURGEON WAS IMPACTING THE TIBIAL TRAY IMPLANT INTO PLACE AND THE IMPACTOR HEAD BROKE WITH THE FINAL MALLET BLOW. THE IMPLANT WAS PROPERLY SEATED SO THERE WAS NO CONSEQUENCE TO THE PATIENT OR NEED FOR ANY FURTHER ACTION. THE INSTRUMENT BROKE INTO 2 PIECES, BOTH OF WHICH WERE RETRIEVED AND DISPOSED OF AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19255555 ↗MalfunctionMay 1, 2024Break; Break
IT WAS REPORTED THAT THE RADAL IMPACTOR BROKE ON INSERTION OF TIB IMPLANT.
Patient problems: Insufficient Information
MAUDE report 19220025 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE COURSE OF NORMAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081111 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE COURSE OF NORMAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081105 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE COURSE OF NORMAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081073 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE COURSE OF NORMAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080215 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE COURSE OF NORMAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080195 ↗MalfunctionApr 8, 2024Break; Break
THE INSTRUMENT WAS BROKEN DURING A TOTAL KNEE REPLACEMENT. THE SURGEON WAS IMPACTING THE TIBIAL TRAY IMPLANT INTO PLACE AND THE IMPACTOR HEAD BROKE WITH THE FINAL MALLET BLOW. THE IMPLANT WAS PROPERLY SEATED SO THERE WAS NO CONSEQUENCE TO THE PATIENT OR NEED FOR ANY FURTHER ACTION. THE INSTRUMENT BROKE INTO (B)(4) PIECES, BOTH OF WHICH WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19067303 ↗
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
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
- SELF CENTERING 2055-13-000Depuy (Ireland) · IMPACTOR324 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