SPECIALIST 96-5383Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 RP TIBIAL TRAY 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 RP tibial tray impactor is a surgical instrument used to press knee implant components into place during surgery. The 64 reports mostly describe the metal tool cracking or breaking apart mid-operation, sometimes leaving pieces that had to be located and removed, and in one case a screw falling out and adding a short delay. No deaths or injuries were reported, and no recalls 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
- 64
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10603295246824), received between Jun 28, 2017 and Jan 24, 2024 — classified as 64 malfunctions.
The most frequently reported specific device problem is “Break” (49 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
- Break49
- Crack6
- Naturally Worn5
- Contamination /Decontamination Problem2
- Detachment of Device or Device Component2
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Consequences Or Impact To Patient33
- No Clinical Signs, Symptoms or Conditions18
- No Information10
- Insufficient Information3
- Not Applicable2
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE MBT TIBIAL IMPACTOR SCREW FELL OUT DURING THE OPERATION. IT WAS LOCATED AND OUT ASIDE. SURGERY WAS DELAYED 2 MINUTES DUE TO THE REPORTED EVENT. ACTION TAKEN WHEN EVENT OCCURRED? GLOVES TAKEN OFF AND CHANGE FOR STERILITY. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18570184 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT A LOAN ORTHOKIT ARRIVED WITH A BROKEN IMPACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17165187 ↗MalfunctionMay 24, 2023Break; Break
IT WAS REPORTED THAT WHILE IMPACTING THE TIBIA THE IMPACTOR TIP SPLIT IN HALF.
Patient problems: Insufficient Information
MAUDE report 16996534 ↗MalfunctionNov 8, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE OFF WHEN IMPACTING TIBIAL BASE PLATE. TIP AND ALL PARTS WERE RECOVERED. CASE WAS NOT DELAYED. NO ADDITIONAL INFORMATION WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15751463 ↗MalfunctionOct 7, 2022Break; Break
THE IMPACTOR BROKE. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15562247 ↗MalfunctionAug 30, 2022Break; Break
IT WAS REPORTED THAT THE SIGMA RP IMPACTOR BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320320 ↗MalfunctionJun 21, 2022Break; Break
IT WAS REPORTED THAT THE RP TIBIAL IMPACTOR HAS A LITTLE CHUNK OUT OF IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14759421 ↗MalfunctionJun 7, 2022Break; Break
IT WAS REPORTED THAT MBT IMPACTOR WAS BROKEN DURING SURGERY. THE HEX BOLT BROKE IN HALF WHILE IMPLANTS THE TIBIA. ALL PIECES WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14622768 ↗MalfunctionMar 19, 2022Break; Break
IT WAS REPORTED THAT THE NUB OF THE SIGMA RP IMPACTOR TIP BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13825158 ↗MalfunctionMar 1, 2022Break; Break
THE TWO INSTRUMENTS ARE BROKEN. DISCOVERY WAS MADE AFTER STERILIZATION PROCESS. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13635866 ↗MalfunctionDec 17, 2021Break; Break
T HANDLE AND HUDSON ADAPTER ARE ALLOWING REAMERS TO SLIP IN THE COUPLING AND LOCK MAKING IT VERY DIFFICULT TO DISCONNECT. WRENCH WILL NOT LOCK OR TIGHTEN PROPERLY. MBT IMPACTOR BROKE ON CONTACT SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13025195 ↗MalfunctionSep 14, 2021Break; Break
IT WAS REPORTED THAT THE IMPACTOR WAS BROKEN AND NO LONGER ATTACHED TO HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12466998 ↗MalfunctionSep 13, 2021Crack; Naturally Worn; Crack; Naturally Worn
IT WAS REPORTED THAT THE 12/14 -2 36MM ARTICULEZE TRIAL HEAD IS DAMAGED AND REQUIRES REPLACEMENT. ALSO LCS TIBIAL IMPACTOR AND KEEL PUNCH IMPACTOR. ALL DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12460714 ↗MalfunctionJul 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE CEMENT STUCK IN BETWEEN THE METAL RIM AND PLASTIC - CSSD COULD NOT REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12203859 ↗MalfunctionMay 18, 2021Break; Break
ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THERE WAS NO ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. NOTHING LEFT IN PATIENT, ALL PIECES RETRIEVED AND ACCOUNTED FOR.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11841138 ↗MalfunctionMay 12, 2021Crack; Crack
EMAIL RECEIVED FROM CSSD DEPARTMENT AT MURDOCH HOSPITAL WITH A LIST OF BROKEN INSTRUMENTS. ALL INSTRUMENTS REMAIN IN ONE PIECE. INSTRUMENTS HAVE BEEN RECEIVED AND INVESTIGATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11811655 ↗MalfunctionMar 29, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE KNEE INSTRUMENT WAS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11584846 ↗MalfunctionJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS ORIGINALLY REPORTED THAT AN INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. THEN PRODUCT WAS RECEIVED AND INVESTIGATION WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118502 ↗MalfunctionNov 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
1. KINDLY CLARIFY WHY SOME INSTRUMENTATION WAS NOT DISASSEMBLED, WAS THERE ANY PRODUCT ISSUE OF THESE PRODUCTS? WHERE APPROPRIATE INSTRUMENTS THAT REQUIRE IT ARE DISASSEMBLED DURING THE INSPECTION PROCESS. IN THESE SPECIFIC CASES THE INSTRUMENTS ARE THEN REASSEMBLED AND PLACED BACK INTO THE TRAY AS THIS IS HOW THEY FIT INTO THE TRAYS. THEY ARE NOT SENT TO CUSTOMERS DISASSEMBLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10919329 ↗MalfunctionNov 13, 2020Break; Break
ADDITIONAL INFORMATION RECEIVED STATED THAT THE INSTRUMENT BROKE INTO TWO PIECES DURING DECONTAMINATION PROCESS. ALL PIECES WERE RETRIEVED AND THE SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10837745 ↗MalfunctionJun 4, 2020Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE POST ON THE RP TIB IMPACTOR HAS WORN DOWN. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10118887 ↗MalfunctionMay 1, 2020Break; Crack; Detachment of Device or Device Component; Break; Crack; Detachment of Device or Device Component
THE METAL PIN ON THE ANTERIOR OF THE IMPACTOR CRACKED AND DISLODGED. THE IMPACTOR IS 15 YEARS OLD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10016995 ↗MalfunctionApr 16, 2020Break; Break
ADDITIONAL INFORMATION RECEIVED THAT THE PART OF THE IMPACTOR BROKE WAS THE COLLAR THAT CONNECTS TO THE PLASTIC. IT WAS BROKEN INTO TWO PIECES AND WAS RETRIEVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9968751 ↗MalfunctionApr 9, 2020Break; Break
IT WAS REPORTED THAT THE HUDSON ADAPTOR WILL NOT ENGAGE ONTO THE REAMER AND THE IMPACTOR BROKE. OFFICE SETS. NO SURGERY WAS EFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9944232 ↗MalfunctionMar 25, 2020Break; Break
IT WAS REPORTED THAT WHEN THEY WERE USING THE TRIAL STEM, THEY NOTICED THE LOCKING PEGS WERE BENT. WHEN THEY WERE ASSEMBLING THE TRIAL THEY NOTICED THAT THE SCREW WOULD NOT SEAT INTO THE SLEEVES. WHEN IMPACTING FINAL TIBIAL IMPLANT 2 IMPACTORS BROKE. ALL INSTRUMENTS HAVE BEEN DISCARDED. NO SURGICAL DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9879434 ↗
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 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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