SPECIALIST 96-6385Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 POLYETHYLENE TIBIAL COMPONENT IMPACTOR · Class 1
All models of SPECIALIST (80)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist 2 polyethylene tibial component impactor is a surgical instrument used to place the tibial insert in knee replacement surgery. The 59 reports mostly describe the plastic impactor breaking or cracking during normal use, sometimes in pieces, with the tool breaking noticed before or during surgery rather than harming the patient. There are no deaths, 1 injury, and 58 malfunctions. No recalls name this device, and no reports were filed in the past 12 months.
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
- 60
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295248279), received between Jun 29, 2017 and Sep 29, 2026 — classified as 1 injury, 59 malfunctions.
The most frequently reported specific device problem is “Break” (46 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break46
- Crack8
- Naturally Worn7
- Material Twisted/Bent4
- Fracture2
- Material Deformation2
- Component Missing1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient20
- No Information5
- Insufficient Information3
- No Code Available1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
It was reported that rubber impactor came off of impaction metal tip.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931362 ↗MalfunctionSep 16, 2024Break; Break
DURING THE PLACEMENT OF THE INSERT, THE INSERT IMPACTOR FRACTURED AND THE ENDS BROKE. THE SURGERY WAS SUCCESSFULLY COMPLETED, WITHOUT AFFECTING THE PATIENT AND WITHOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20229629 ↗MalfunctionApr 10, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE COURSE OF NORMAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080201 ↗MalfunctionApr 9, 2024Break; Break
IT WAS REPORTED THAT IMPACTOR HANDLE BROKE WHEN IMPACTING INSERT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19069724 ↗MalfunctionDec 6, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED, THAT THE DEVICE WAS BROKEN AND NOT CRACKED. THERE WAS A SURGICAL DELAY IN A ABOUT A MINUTE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18275597 ↗MalfunctionDec 6, 2023Break; Break
IT WAS REPORTED THAT THE IMPACTOR IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 18274149 ↗MalfunctionNov 29, 2023Break; Break
PART OF PLASTIC COMPONENT BROKE OFF. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18234485 ↗MalfunctionNov 15, 2023Break; Break
IT WAS REPORTED THAT THE POLY TIB COMP IMPACTOR WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145923 ↗MalfunctionNov 13, 2023Break; Break
IT WAS REPORTED THAT THE TIBIAL IMPACTOR IS BROKEN. IT WAS NOTICED AFTER THE OPERATION SO HAD NO EFFECT ON THE PATIENT OR PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18118676 ↗MalfunctionOct 17, 2023Break; Break
IT WAS REPORTED THAT THE TIBIA INSERT IMPACTOR SPLIT. THERE WAS NO DELAY. YES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE BROKEN IMPACTOR. THERE WAS NO ADDITIONAL TIME, THE BROKEN FRAGMENT WAS REMOVED AND THERE WAS NO BURN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17949138 ↗MalfunctionSep 28, 2023Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE WHILE IMPACTING IMPLANT; NO PATIENT CONSEQUENCE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: UNKNOWN, 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 17835992 ↗MalfunctionSep 7, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: 1. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - NO. 2. WHICH PART OF THE IMPACTOR WAS CRACKED? - SIDES. 3. IF DEPUY SYNTHES INSTRUMENTATION BROKE DURING SURGERY, WERE ALL PIECES RETRIEVED FROM THE PATIENT?- YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17698329 ↗MalfunctionAug 10, 2023Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE IN TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17498715 ↗MalfunctionJun 28, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED. 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? IT DID NOT LEAD TO DELAY IN SURGERY. 2. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? THERE WAS NO CONSEQUENCE FOR THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17218218 ↗MalfunctionMar 1, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT WHEN PUTTING TRAYS BACK TOGETHER, IT WAS NOTICED A CRACK IN TIBIAL INSERT IMPACTOR AND THEN WHILE FIDDLING WITH IT, IT BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16460437 ↗MalfunctionDec 28, 2022Crack; Crack
IT WAS REPORTED THAT THE SIGMA IMPACTOR CRACKED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16061639 ↗MalfunctionDec 2, 2022Break; Break
IT WAS REPORTED THAT PFC TIBIAL POLY IMPACTOR BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15904410 ↗MalfunctionNov 7, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15745104 ↗MalfunctionOct 4, 2022Crack; Naturally Worn; Crack; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT HAS WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15537427 ↗MalfunctionAug 15, 2022Break; Break
IT WAS REPORTED THAT THE TIBIAL INSERTER BROKE INTO 2 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15224813 ↗MalfunctionJul 27, 2022Break; Break
IT WAS REPORTED THAT POLY IMPACTOR IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15114031 ↗MalfunctionJun 28, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE. NO PATIENT IMPACT, DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14840711 ↗MalfunctionJun 27, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE. NO PATIENT IMPACT, DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14829169 ↗MalfunctionJun 27, 2022Break; Break
IT WAS REPORTED THAT THE LOCKING BARREL ON THE IMPACTOR WAS BROKEN. NO PATIENT IMPACT, DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14829149 ↗MalfunctionJun 27, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR WAS BROKEN. NO PATIENT IMPACT, DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14829140 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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