P.F.C. SIGMA 96-1045Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA CRUCIATE SUBSTITUTING BOX TRIAL SZ 5 · Class 1
All models of P.F.C. SIGMA (487)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Sigma size 5 cruciate box trial is a surgical template used to fit and check implant sizing during knee replacement. The 49 reports mostly describe hardware problems with the trial's screw and threads: stripped or rounded-off grub screws that no longer hold the box to the femoral trial, screws wedging or cold-welding in place, and parts found bent, twisted, worn or missing. None of the reports describe deaths or injuries, and most note no effect on the patient. 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
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295234739), received between Dec 8, 2017 and May 15, 2025 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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
- Device-Device Incompatibility14
- Component Missing12
- Material Twisted/Bent12
- Naturally Worn11
- Material Deformation8
- Break5
- Use of Device Problem5
- Mechanical Jam4
Patient problems
- No Consequences Or Impact To Patient30
- No Clinical Signs, Symptoms or Conditions17
- No Code Available4
- Insufficient Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SCREW IN THE BOX TRIAL IS STRIPPED. IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22028322 ↗MalfunctionJun 4, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE BOX WAS STRIPPED OUT INSIDE THE FEMORAL TRIAL.
Patient problems: Insufficient Information
MAUDE report 19463592 ↗MalfunctionMar 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT BOX TRIAL IS STRIPPED, SCREWDRIVER DOES NOT CAPTURE SCREWS. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16618562 ↗MalfunctionMar 14, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE SPECIFIC ALLEGATION AGAINST THE REPORTED PRODUCT? PLEASE CLARIFY. B. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? C. IF DEPUY SYNTHES INSTRUMENTATION BROKE DURING SURGERY, WERE ALL PIECES RETRIEVED FROM THE PATIENT? D. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? A. THE SCREW IN THE TRIAL WILL NOT MOVE. B. NO SURGICAL DELAY. C. NOTHING BROKE. D. NO ADVERSE CONSEQUENCES WERE ENCOUNTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16537206 ↗MalfunctionJan 4, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE SCREW ATTACHMENT MECHANISM WAS NO LONGER SECURING THE SIGMA SIZE 5 BOX TRIAL TO THE FEMORAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16097129 ↗MalfunctionDec 27, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
DID THE EVENT HAPPEN DURING A PROCEDURE? YES. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: GRUB SCREW INSIDE USED TO TIGHTEN BOX TO TRIAL IS ROUNDED OFF ¿ UNABLE TO CONNECT TO TRIAL AND NO LONGER FIT FOR PURPOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16051653 ↗MalfunctionDec 13, 2022Mechanical Jam; Mechanical Jam
FAULT REPORTED: GRUB SCREW IS WEDGED / COLD WELDED, CANNOT BE MOVEDNO ADDITIONAL TIME WAS ADDED TO THE OPERATION I UNDERSTAND, FAULT WAS FOUND BY STERILE SERVICES STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15966241 ↗MalfunctionJul 27, 2022Break; Break
SCREW BROKEN IN BOX TRIAL. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15115782 ↗MalfunctionMay 13, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SIGMA SIZE 5 PS BOX TRIAL IS STRIPPED AND WILL NOT THREAD INTO THE FEMORAL TRIAL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14397442 ↗MalfunctionMay 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INTERNAL SCREW IS LOCKED AND THE HEAD IS TWISTED OF REFERENCE 961048 FEMORAL TEST BOX OF 2.5, AND REFERENCE 961045 FEMORAL TEST BOX OF 5 DOES NOT HAVE THE INTERNAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316255 ↗MalfunctionApr 28, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SIGMA SIZE 5 NOTCH TRIAL IS STRIPPED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14243311 ↗MalfunctionMar 24, 2022Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn
IT WAS REPORTED THAT AS THE SCRUB WAS TRYING TO PUT THE SIZE 5 BOX TRIAL ON THE SIZE 5 FEMORAL TRIAL, THE SCREW THAT CONNECTS THE TWO WAS DAMAGED AND WOULD NOT TURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13889855 ↗MalfunctionDec 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
SIZE 5 BOX, SCREW IS STUCK. SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5 MINUTES , WAS THE PROCEDURE SUCCESSFULLY COMPLETED? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13061055 ↗MalfunctionNov 12, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SCREW INSIDE BOX HAS TIGHTENED AND WILL NOT UNDO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12803561 ↗MalfunctionJul 9, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SCREW WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12145371 ↗MalfunctionMay 3, 2021Material Integrity Problem; Material Integrity Problem
AFTER THE CONFERENCE, THE FOLLOWING DIVERGENCES WERE DETECTED: THE SCREW IN QUESTION IS NOT HOLDING IN THE FEMUR TEST. PRODUCT: (B)(4). BATCH: NB68958. THE SCREW HEAD IS DAMAGED. PRODUCT: (B)(4). BATCH: SO2031909.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11760111 ↗MalfunctionJan 13, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SIGMA FEMORAL TRIAL AND BOX. BOX IS STRIPPED AND WON'T COME OUT. ATTUNE TIBIAL IMPACTOR BROKE. ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11164238 ↗MalfunctionDec 22, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
REF: 961045 -PFC SIGMA SZ 5 FEMORAL COMPONENT TRIAL BOX, INTRAOPERATIVELY WHEN ASSEMBLING THIS PIECE IN THE SZ 5 FEMORAL TRIAL COMPONENT IT IS NOT POSSIBLE SINCE THE LOCKING SCREW OF THE TRIAL BOX IS ROLLED. IT DIDN'T WORK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11057098 ↗MalfunctionOct 16, 2020Component Missing; Device-Device Incompatibility; Component Missing; Device-Device Incompatibility
THE SCREW, WHICH ALLOWS TO MAINTAIN THE TEST BLOCK, DOES NOT HAVE A STOPPER AS USUAL. ONCE THE SCREW GOES OUT, IT WAS IMPOSSIBLE TO REPLACE IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10690182 ↗MalfunctionOct 16, 2020Component Missing; Device-Device Incompatibility; Component Missing; Device-Device Incompatibility
THE SCREW, WHICH ALLOWS TO MAINTAIN THE TEST BLOCK, DOES NOT HAVE A STOPPER AS USUAL. ONCE THE SCREW GOES OUT, IT WAS IMPOSSIBLE TO REPLACE IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10690181 ↗MalfunctionSep 14, 2020Use of Device Problem; Component Missing; Device-Device Incompatibility; Use of Device Problem; Component Missing; Device-Device Incompatibility
THE SCREW, WHICH ALLOWS TO MAINTAIN THE TEST BLOCK, DOES NOT HAVE A STOPPER AS USUAL. ONCE THE SCREW GOES OUT, IT WAS IMPOSSIBLE TO REPLACE IT. THIS ISSUE OCCURRED ON SEVERAL DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10531885 ↗MalfunctionSep 14, 2020Use of Device Problem; Component Missing; Device-Device Incompatibility; Use of Device Problem; Component Missing; Device-Device Incompatibility
THE SCREW, WHICH ALLOWS TO MAINTAIN THE TEST BLOCK, DOES NOT HAVE A STOPPER AS USUAL. ONCE THE SCREW GOES OUT, IT WAS IMPOSSIBLE TO REPLACE IT. THIS ISSUE OCCURRED ON SEVERAL DEVICES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10531877 ↗MalfunctionSep 14, 2020Use of Device Problem; Component Missing; Device-Device Incompatibility; Use of Device Problem; Component Missing; Device-Device Incompatibility
THE SCREW, WHICH ALLOWS TO MAINTAIN THE TEST BLOCK, DOES NOT HAVE A STOPPER AS USUAL. ONCE THE SCREW GOES OUT, IT WAS IMPOSSIBLE TO REPLACE IT. THIS ISSUE OCCURRED ON SEVERAL DEVICES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10531839 ↗MalfunctionAug 17, 2020Component Missing; Component Missing
THE SCREW, WHICH ALLOWS TO MAINTAIN THE TEST BLOCK, DOES NOT HAVE A STOPPER AS USUAL. ONCE THE SCREW GOES OUT, IT WAS IMPOSSIBLE TO REPLACE IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10414837 ↗MalfunctionAug 14, 2020Use of Device Problem; Component Missing; Use of Device Problem; Component Missing
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS NOT USED FOR A SURGERY, IT WAS A NEW ONE.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10408698 ↗
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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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