SPECIALIST 96-6180Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 FEMORAL IMPACTOR · Class 1
Quick summary
This DePuy Specialist 2 femoral impactor is a surgical tool used to hammer femoral implants into place. Of its 173 reports, most describe breakage and screws that strip, along with parts coming loose. The reports mention no deaths and no injuries, 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
- 173
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 10603295247203), received between Sep 8, 2017 and Jul 2, 2026 — classified as 173 malfunctions.
The most frequently reported specific device problem is “Break” (110 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
- Break110
- Naturally Worn24
- Unintended Movement20
- Loose or Intermittent Connection11
- Material Deformation11
- Material Twisted/Bent10
- Detachment of Device or Device Component7
- Device-Device Incompatibility7
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- No Consequences Or Impact To Patient67
- Insufficient Information9
- No Information5
- No Code Available2
- Not Applicable2
Recent adverse event reports
The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THE IMPACTORS WERE SCRATCHED TO A POINT WHERE THEY CANNOT BE REPROCESSED DUE TO POSSIBLE COMPROMISED STERILITY, PER FACILITIES. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690364 ↗MalfunctionJun 24, 2026Material Deformation
IT WAS REPORTED THAT FEMORAL IMPACTOR SCREWS ARE STRIPPED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608644 ↗MalfunctionJun 24, 2026Material Deformation
IT WAS REPORTED THAT SCREWS ON FEMORAL IMPACTOR ARE STRIPPED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608389 ↗MalfunctionApr 3, 2026Break; Material Deformation
IT WAS REPORTED THAT FEMORAL IMPACTOR SCREWS WERE STRIPPED. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775890 ↗MalfunctionNov 21, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE IMPACTOR BROKE APART, AND THE SCREWS WERE STRIPPED. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617020 ↗MalfunctionNov 5, 2025Material Deformation; Material Deformation
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A KNEE SURGERY, THE SCREWS ON THE FEMUR IMPACTOR WERE STRIPPED AND WOULD NOT THREAD BACK ON TO THE IMPACTOR, RENDERING IT UNUSABLE FOR SURGERY. ALSO, A WIDGET WAS USED TO HIT OFF THE FEMUR AND A PIECE OF THE WIDGET BROKE OFF. ALL PIECES WERE RETRIEVED AND THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476639 ↗MalfunctionAug 28, 2025Break; Break
IT WAS REPORTED THAT FEMORAL MODULAR IMPACTOR IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912934 ↗MalfunctionJan 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE FEMORAL IMPACTOR WAS PASSED TO THE SPECIALIST, IT WAS COMPLETELY DISASSEMBLED. NORMALLY THIS CAN BE ADJUSTED WITH THE T-KEY OF THE MOTOR BUT UNFORTUNATELY THE HOLE THAT HAS TO TIGHTEN IS ALREADY COMPLETELY PEELED. THEREFORE A PROMPT SOLUTION OF JOINING THE PIECES WITH STERILE MICROPORE WAS GIVEN AND THUS THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21245977 ↗MalfunctionOct 17, 2024Break; Break
COMPLAINT ABOUT PRODUCTS ON REQUEST FOR REPLACEMENT OF COMPONENTS IN KITS. REASON FOR CONTACT: BREAKDOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470010 ↗MalfunctionOct 1, 2024Break; Break
IT WAS REPORTED THAT FEMORAL IMPACTOR BROKE DURING IMPACTION.
Patient problems: Insufficient Information
MAUDE report 20342638 ↗MalfunctionSep 3, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
DURING THE SURGERY WHEN USING THE IMPACTOR IT IS EVIDENT THAT THIS IS DAMAGED AND EVEN ARRIVED UNARMED. NO SOLUTION IS GIVEN IN THIS REGARD SINCE NOT HAVING ANOTHER OPTION TO SOLVE. IT WAS NECESSARY TO WORK WITH THIS SAME IMPACTOR DURING THE SURGERY, PERFORMING MANEUVERS INTRA SURGICALLY TO COVER THE NEED OF THE MOMENT. THIS ALSO GENERATED A DELAY IN THE SURGICAL TIMES OF APPROXIMATELY TWENTY (20) MINUTES. EVEN SO, IT WAS POSSIBLE TO FINISH THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT. THE SURGERY WAS FINISHED AND PATIENT'S CONDITION WAS STABLE AND WITHOUT ADDITIONAL COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20124283 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT THE IMPACTORS BROKE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20085304 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT THE IMPACTORS BROKE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20085278 ↗MalfunctionAug 15, 2024Break; Off-Label Use; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Off-Label Use; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THE FEMORAL IMPACTOR CAME APART INTO TWO PIECES WHICH BECAME IMPACTED AND WITH THIS IT WAS POSSIBLE TO JOIN AGAIN. THERE WAS NO DELAY OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19991749 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR CHIPPED. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19930887 ↗MalfunctionMay 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT BLACK PORTION OF DOUBLE BANGER NO LONGER CONNECTED.
Patient problems: Insufficient Information
MAUDE report 19339654 ↗MalfunctionJan 31, 2024Break; Break
IT WAS REPORTED THAT THE DEVICE SNAPPED WHILE IMPACTING FEMUR. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18613140 ↗MalfunctionJan 11, 2024Break; Break
THE ITEM BROKE WHILE IN USE DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18493866 ↗MalfunctionJan 5, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SCREWS THAT HOLD SECONDARY IMPACTOR TOGETHER WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18452322 ↗MalfunctionDec 11, 2023Break; Naturally Worn; Break; Naturally Worn
BLACK PLASTIC PART OF FEM IMPACTOR BROKE OFF THE METAL PIECE. THREADING ON THE SCREWS WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18307639 ↗MalfunctionNov 6, 2023Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18080947 ↗MalfunctionOct 26, 2023Break; Break
IT WAS REPORTED THAT THE SIGMA FEMORAL IMPACTOR BROKE INTO TWO PIECES ON IMPACTOR PIECE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18012862 ↗MalfunctionOct 11, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A TKA. THE IMPACTOR IN QUESTION WAS USED IN THE SURGERY. DURING SURGERY, THE IMPACTOR IN QUESTION WAS DAMAGED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17913456 ↗MalfunctionOct 3, 2023Break; Break
IT WAS REPORTED THAT INSTRUMENT BROKE DURING KNEE SURGERY TODAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861766 ↗MalfunctionOct 3, 2023Break; Break
IT WAS REPORTED THAT INSTRUMENT BROKE DURING KNEE SURGERY TODAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861719 ↗
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.