P.F.C. 86-5189Recalls & reported problems
Depuy (Ireland) · P.F.C. PRESS FIT ROD WRENCH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy P.F.C. press-fit rod wrench appears in 92 adverse event reports, with no deaths and no injuries. Reports mostly describe the wrench jamming, breaking, or becoming bent or worn, which can stop it from tightening or loosening implant parts. 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
- 92
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 10603295216759), received between Jul 21, 2017 and Jan 7, 2026 — classified as 92 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (17 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
- Mechanical Jam17
- Appropriate Device Problem Term/Code Not Available13
- Device-Device Incompatibility13
- Break11
- Material Deformation9
- Mechanical Problem8
- Naturally Worn7
- Bent6
Patient problems
- No Consequences Or Impact To Patient56
- No Clinical Signs, Symptoms or Conditions24
- No Information8
- Insufficient Information2
- Not Applicable2
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Material Deformation
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE SROM HINGE KNEE INSTRUMENTS WERE FOUND TO BE WORN AND STRIPPED. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23992247 ↗MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE IMPACTED PRODUCT WON'T LOOSEN OR TIGHTEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831863 ↗MalfunctionOct 24, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BACK END OF THE WRENCH BROKE OFF AND WILL NOT TIGHTEN OR LOOSEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378956 ↗MalfunctionSep 10, 2025Structural Problem; Device-Device Incompatibility; Structural Problem; Device-Device Incompatibility
DURING A REVISION TKR WHEN PUTTING TOGETHER IMPLANTS IT WAS NOTICED THAT THE PFC STEM WRENCH THAT SLIDES INTO THE SLOTS OF THE UNIVERSAL STEM WAS NOT ENGAGING AND BROKEN. THE SURGERY WAS DELAYED FOR AN UNKNOWN AMOUNT OF TIME. THE SURGEON FOUND AN INSTRUMENT TO TIGHTEN THE STEM ONTO THE SLEEVE FOR IMPLANTATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017629 ↗MalfunctionApr 30, 2025No Apparent Adverse Event; No Apparent Adverse Event
BLIND UNIT RECEIVED. UPON RECEIPT OF THE DEVICE FOR MANUFACTURER'S INVESTIGATION THE INSTRUMENT WAS FOUND TO BE DEFORMED.
Patient problems: Insufficient Information
MAUDE report 21935289 ↗MalfunctionOct 1, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENT WAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. UPON RETURN OF THE PART TO THE MANUFACTURER, IT WAS IDENTIFIED THAT THE ITEM WAS BENT, SCRATCHED/NICKED, AND WOULD NOT TENSION/TIGHTEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20345741 ↗MalfunctionOct 3, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
THE ROD WRENCH JAMMED IN THE OPEN POSITION AND COULD NOT BE ADJUSTED TO FIT THE PFC STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860730 ↗MalfunctionAug 28, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17631000 ↗MalfunctionJun 29, 2023Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THE WRENCHES WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224789 ↗MalfunctionJun 29, 2023Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE WRENCHES WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224721 ↗MalfunctionJun 29, 2023Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THE WRENCHES WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224689 ↗MalfunctionMay 8, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE BROACH WOULD NO LONGER LOCK THE STEM ONTO IT, AND THE WRENCH WOULD NOT MOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16888096 ↗MalfunctionApr 21, 2023Structural Problem; Mechanical Jam; Structural Problem; Mechanical Jam
IT WAS REPORTED THAT THE KNOB WAS GETTING STUCK AND PREVENTED HIM FROM TIGHTENING THE WRENCH ONTO THE STEM PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16784861 ↗MalfunctionJan 27, 2023Break; Break
IT WAS REPORTED THAT THE WRENCH WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252969 ↗MalfunctionJan 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE WRENCH WOULD NOT ASSEMBLE AS INTENDED. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16114345 ↗MalfunctionJul 13, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE WRENCH WILL NOT OPEN. IT APPEARED THAT THE INTERNAL PART IS SLIGHTLY BENT. NOT BROKEN INTO TWO PARTS. IT DID NOT AFFECT THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15000879 ↗MalfunctionMar 24, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STEM WRENCH DOESN¿T TIGHTEN UP ENOUGH AROUND THE STEM ANYMORE. INTERNAL MECHANISM MUST BE BROKEN BUT NOTHING VISIBLY DAMAGED JUST FROM LOOKING AT IT. NO DELAY TO SURGERY OR HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13890026 ↗MalfunctionDec 17, 2021Device-Device Incompatibility; Device-Device Incompatibility
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 13025196 ↗MalfunctionDec 7, 2021Mechanical Jam; Mechanical Jam
DURING A REVISION TKA, THE SURGEON WAS ATTEMPTING TO ASSEMBLE THE FEMORAL STEM TO THE FEMORAL COMPONENT; HOWEVER, THE WRENCH PRESS WAS JAMMED AND WOULD NOT LOOSEN TO ALLOW FOR THE SURGEON TO FIT THE IMPLANT THROUGH IT. TO AVOID ANY COMPLICATIONS, A SECOND WRENCH PRESS WAS OPENED AND USED TO ASSEMBLE THE IMPLANTS INSTEAD. THIS CAUSED A 1 MIN DELAY WHILE WAITING TO OPEN A DIFFERENT WRENCH PRESS. THE SECOND WRENCH PRESS WORKED AS PLANNED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE OR ANY FURTHER DELAY. IF YES, NUMBER OF MINUTES: 1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12952474 ↗MalfunctionSep 14, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE WRENCH DOES NOT GRIP AS INTENDED. THE INSTRUMENT IS WORN OUT. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12466589 ↗MalfunctionSep 10, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE KNOB ON STEM WRENCH IS TOO TIGHT AND VERY DIFFICULT TO ADJUST. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12452455 ↗MalfunctionJul 15, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING REVISION SURGERY THE CLAMPING MECHANISM OF THE FOLLOWING INSTRUMENT WAS VERY STIFF AND DIFFICULT TO USE. NO SIGNIFICANT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172501 ↗MalfunctionMay 10, 2021Material Deformation; Material Deformation
UNIVERSAL STEM WAS DAMAGED DURING IMPLANT ASSEMBLY BY MISUSE. THE PRONGS WERE DEFORMED BY TIGHTENING THE EXTENSION WRENCH (865189) STRONGLY TO THE STEM IN THE PLACE BETWEEN THE SLOTS. THIS WAS DUE TO INSUFFICIENT EXPLANATION IN SURGICAL TECHNIQUE - THERE IS NO SPECIFIED PLACE TO USE THE WRENCH ON THE STEM. SURGERY DELAYED 5 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11797651 ↗MalfunctionMay 7, 2021Break; Break
IT WAS REPORTED THAT THE WRENCH WHICH TIGHTENS ON THE IMPLANT STEM TO THE SLEEVE BROKE WHILE TRYING TO TIGHTEN. A SURGICAL DELAY OF 3 MINUTES WAS NOTED.
Patient problems: Insufficient Information
MAUDE report 11791861 ↗MalfunctionApr 29, 2021Mechanical Jam; Mechanical Jam
ADDITIONAL INFORMATION RECEIVED WAS RECEIVED INDICATED THAT THE SLEEVE TAPER EXTRACTOR HAD STRIPPED THREADS. THE STEM WRENCH FUNCTION HAD NOT BEEN LUBRICATED APPROPRIATELY MAKING THE ACTION STIFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11749423 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 reports
- ATTUNE 2546-00-420Depuy (Ireland) · WRENCH31 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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