P.F.C. 86-6887Recalls & reported problems
Depuy Orthopaedics, Inc. · P.F.C. TIBIAL FLUTED ROD TRIAL 20mm x 115mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295217695), received between Jul 25, 2018 and Oct 24, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2019Break; Break
MalfunctionJul 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
PRODUCT NAME: PFC STEM TRIAL EXTRACTOR; PRODUCT CODE: 865226; LOT/BATCH/EXP: TBC; WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO; DID THE EVENT HAPPEN DURING A PROCEDURE? YES; WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES; EVENT OUTCOME/HOW WAS IT MANAGED? BROKEN INSTRUMENT REMOVED USING COLD CHISEL AND MOLEGRIPS. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY ¿ SURGERY DELAY WAS APPROXIMATELY 20 MINUTES. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? YES AFTER CLEANING AND DECON. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: THE OPERATION WAS A DISTAL FEMUR TO SLEEVE CASE. THE SURGEON HAS BEEN USING THE KIT FOR OVER 5 YEARS AND IS A KOL AND VISITATION FOR US. AFTER THE TRIAL THE SURGEON REMOVED THE TRIAL COMPONENTS AND, AS IF OFTEN THE CASE, IN THESE PATIENTS THE 31MM SLEEVE TRIAL AND 20 X 115 STEM TRIAL DISASSOCIATED FROM THE TRIAL DISTAL FEMUR. THE SURGEON INSERTED THE STEM TRIAL EXTRACTOR, ATTACHED THE SLAP HAMMER AND TRIED TO REMOVE THE TRIAL SLEEVE AND STEM. THE END OF THE INSTRUMENT SHEAR OFF AT THE POINT WHE
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7717762 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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