SPECIALIST 96-6115Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK · Class 1
All models of SPECIALIST (80)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist 2 distal femoral cutting block is used to guide bone cuts during knee replacement surgery. The 34 reports mostly describe the cutting block wearing out, sticking or jamming, being scratched or deformed, and pins that no longer fit or grip, sometimes leading to inaccurate cuts or blocks that would not assemble and other instruments being used to continue. There are 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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295246862), received between Oct 19, 2017 and Aug 15, 2024 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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
- Device-Device Incompatibility15
- Material Deformation9
- Mechanical Jam7
- Naturally Worn5
- Physical Resistance/Sticking3
- Break2
- Material Twisted/Bent2
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient19
- No Clinical Signs, Symptoms or Conditions10
- Not Applicable4
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN PUMP WHEN USED TO REMOVE THE PINS DOES NOT HAVE GOOD GRIP. THERE WAS NO DELAY OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19991865 ↗MalfunctionApr 9, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE CUTTING BLOCK IS DAMAGED. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS FOUND THE BLOCK WAS SCRATCHED/NICKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070414 ↗MalfunctionMar 1, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE SAW CAPTURE SLOT HAS WIDENED OVER TIME AND IS NOT GIVING ACCURATE CUTS. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18816517 ↗MalfunctionMar 1, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE SAW CAPTURE SLOT HAS WIDENED OVER TIME AND IS NOT GIVING ACCURATE CUTS. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18816494 ↗MalfunctionMar 1, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
CAN YOU PLEASE CLARIFY WHAT IS THE SPECIFIC ALLEGATION OF THE REPORTED DEVICE? THE CUTTING BLOCKS ARE SO OLD THE CUTTING CLOT FOR THE SAW IS WORN MEANING THE SAW HAS MORE ROOM TO DEVIATE IN THE WRONG PLANE. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO THERE WAS NO SPECIFIC SURGERY EVENT THAT THIS HAPPENED ON AS EXPLAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18816480 ↗MalfunctionOct 19, 2023Mechanical Jam; Mechanical Jam
THE DISTAL FEMORAL CUTTING BLOCK WAS STUCK IN A CLOSED POSITION AND IT WAS NOT POSSIBLE TO ASSEMBLE CORRECTLY. ANOTHER SET OF INSTRUMENTS WERE USED TO ALLOW FOR THE SURGERY TO CONTINUE. PROCEDURE SUCCESSFULLY COMPLETED WITH NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17967524 ↗MalfunctionAug 19, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE DISTAL FEMORAL CUTTING BLOCK PIN HOLES ARE WORN DOWN. PINS DO NOT FIT ANYMORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15258273 ↗MalfunctionApr 22, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SPRING IS STUCK ON DISTAL CUTTING BLOCK. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189457 ↗MalfunctionMar 25, 2022Material Integrity Problem; Material Integrity Problem
DAMAGED DEVICES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904572 ↗MalfunctionMar 17, 2022Device-Device Incompatibility; Device-Device Incompatibility
INSTRUMENTS ARE JAMMED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13802353 ↗MalfunctionJul 14, 2020Break; Break
IT WAS REPORTED THAT THE SPRING LOADED BUTTON BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10272233 ↗MalfunctionMay 11, 2020Device-Device Incompatibility; Device-Device Incompatibility
MATCH ISSUE. IT WAS REPORTED THAT DURING THE PFC OPERATION, NOTED 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. NO BACK-UP TOOLS ON THE SITE, THE SURGEON CUT THE BONE IN ACCORDING TO HIS EXPERIENCES. THE SURGERY DELAYED ABOUT 40MINS. THE PATIENT IS STABLE AND IN HOSPITAL NOW. THESE TWO TOOLS WERE 1ST TIME USE.
Patient problems: No Code Available; Not Applicable
MAUDE report 10044845 ↗MalfunctionMay 8, 2020Device-Device Incompatibility; Device-Device Incompatibility
MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCT ALSO WITH THE SAME ISSUE: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10039647 ↗MalfunctionMay 8, 2020Device-Device Incompatibility; Device-Device Incompatibility
MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCTS ALSO WITH THE SAME ISSUE AS THE PHOTO SHOWS: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10039604 ↗MalfunctionMay 8, 2020Device-Device Incompatibility; Device-Device Incompatibility
MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCTS ALSO WITH THE SAME ISSUE AS THE PHOTO SHOWS: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10039601 ↗MalfunctionMay 8, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS A MATCH ISSUE. THE LOCATG DEV OUTRIGGER COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF THE FEM CUTTING BLOCK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10039101 ↗MalfunctionMay 6, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS A MATCH ISSUE. THE SP*2 FEM LOCATG DEV OUTRIGGER COULD NOT PASS THROUGH THE SLOT/HOLE OF THE SP*2 DISTAL FEM CUTTING BLOCK. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10030704 ↗MalfunctionMay 4, 2020Device-Device Incompatibility; Device-Device Incompatibility
MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCT ALSO WITH THE SAME ISSUE: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10021050 ↗MalfunctionMay 4, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10021042 ↗MalfunctionMay 4, 2020Device-Device Incompatibility; Device-Device Incompatibility
MATCH ISSUE. IT WAS REPORTED THAT AS THE EVENT (B)(4) HAPPENED, CONSIDERING SAFETY, THE DISTRIBUTOR CHECKED THE SAME LOT PRODUCTS, NOTED THE IMPACT PRODUCT ALSO WITH THE SAME ISSUE: 966112 COULD NOT PASS THE WAY THROUGH THE SLOT/ HOLE OF 966115. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10021029 ↗MalfunctionFeb 19, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE DRILL BIT THAT THE SURGEON WAS USING FROM THE DEPUY DRILL BIT AND STEINMAN PIN PACKET (REF.86-4192, LOT J68550W), BINDED UP IN THE RIGHT LATERAL HOLE OF THE DISTAL FEMORAL CUTTING BLOCK THAT THE SURGEON WAS USING. THE DRILL WAS BEING USED TO DRILL THE HOLES IN THE PATIENT'S DISTAL FEMUR, FOR THE STEINMAN PINS THAT ARE USED TO PIN THE CUTTING BLOCK TO THE FEMUR. THE SURGEON THEN USED A PIN PULLER TO REMOVE THE STUCK (WEDGED) DRILL BIT FROM THE CUTTING BLOCK. A SECOND DRILL BIT WAS USED TO DRILL THE HOLE. IT WAS INSERTED IN REVERSE ROTATION, SO IT TOO WOULD NOT BIND UP IN THE RIGHT LATERAL HOLE OF THE CUTTING. THE SURGEON THEN BELIEVES THAT THERE MAY BE SOMETHING WRONG WITH THE HOLE IN THE CUTTING BLOCK, SINCE HE SAID THE SAME THING HAPPENED TO HIM TWO WEEKS PRIOR. SALES REP ASSURED THAT HE WOULD REPORT THE INCIDENT AND REQUEST THAT A REPLACEMENT CUTTING BLOCK BE ORDER FOR THE DEPUY SYNTHES LOANER INSTRUMENTATION SET. A REPLACEMENT BLOCK IS NEEDED BEFORE HE USES THE SAME SET OF INSTRUMENTS AT THE SAME LOCATION ON (B)(6) 2020.
Patient problems: Not Applicable
MAUDE report 9727249 ↗MalfunctionFeb 18, 2020Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRILL BIT THAT SURGEON WAS USING, FROM THE DEPUY DRILL BIT AND STEINMAN PIN PACKET (REF. 86-4192, LOT J68550W), BINDED UP IN THE RIGHT LATERAL HOLE OF THE DISTAL FEMORAL CUTTING BLOCK HE WAS USING. THE DRILL WAS BEING USED TO DRILL THE HOLES IN THE PATIENT'S DISTAL FEMUR, FOR THE STEINMAN PINS THAT ARE USED TO PIN THE CUTTING BLOCK TO THE FEMUR. SURGEON THEN USED A PIN PULLER TO REMOVE THE STUCK (WEDGED) DRILL BIT FROM THE CUTTING BLOCK. A SECOND DRILL BIT WAS USED TO DRILL THE HOLE. IT WAS INSERTED IN REVERSE ROTATION, SO IT TOO WOULD NOT BIND UP IN THE RIGHT LATERAL HOLE OF THE CUTTING. SURGEON BELIEVES THAT THERE MAY BE SOMETHING WRONG WITH THE HOLE IN THE CUTTING BLOCK, SINCE HE SAID THE SAME THING HAPPENED TO HIM TWO WEEKS PRIOR. THE SALES REP ASSURED THE SURGEON THAT HE WOULD REPORT THE INCIDENT AND REQUEST THAT A REPLACEMENT CUTTING BLOCK BE ORDER FOR THE DEPUY SYNTHES LOANER INSTRUMENTATION SET. A REPLACEMENT BLOCK IS NEEDED BEFORE HE USES THE SAME SET OF INSTRUMENTS AT THE SAME LOCATION ON (B)(6) 2020.
Patient problems: Not Applicable
MAUDE report 9721618 ↗MalfunctionNov 4, 2019Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking; Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking
SP2 DISTAL FEM CUTTING BLOCK CAN'T BE MATCHED WITH (966112) SP*2 FEM LOCATG DEV OUTRIGGER BECAUSE IT GETS STUCK. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9274563 ↗MalfunctionOct 25, 2019Mechanical Jam; Mechanical Jam
RELEASE BUTTON IS STUCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240830 ↗MalfunctionOct 9, 2019Material Deformation; Naturally Worn; Unintended Movement; Material Deformation; Naturally Worn; Unintended Movement
THE PARTS DON'T CLIP WELL TOGETHER. THE MEASURE IS NOT GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9171780 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- SIGMA LCS 9505-01-230Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- ATTUNE 2544-00-522Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC58 reports
- SIGMA LCS 9505-01-229Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA 2024-40-100Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 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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