NA 02.221.103SRecalls & reported problems
Synthes GmbH · 3.5MM VA PPFX GT RING ATTCHMT PLATE/LARGE/LEFT/STERILE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982276049), received between Jan 14, 2025 and Aug 14, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 Incompatibility4
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50252857 ↗MalfunctionMay 7, 2026Device-Device Incompatibility
IT WAS REPORTED DURING A PPFX SURGERY THAT THE VA LOCKING PPFX GREATER TROCHANTER RING COULD NOT BE THREADED ONTO THE PROXIMAL FEMUR PLATE. ATTEMPTS TO ENGAGE A SECOND RING PLATE ALSO FAILED, RESULTING IN THE INABILITY TO IMPLANT ANY RING PLATE. THE EVENT LED TO A SIGNIFICANT DELAY OF APPROXIMATELY 25 MINUTES, AND THE FRACTURE COULD NOT BE FIXED AS REQUIRED. THERE WAS REPORTED PATIENT HARM, BUT NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114027 ↗MalfunctionMay 7, 2026Device-Device Incompatibility
IT WAS REPORTED DURING A PPFX SURGERY THAT THE VA LOCKING PPFX GREATER TROCHANTER RING COULD NOT BE THREADED ONTO THE PROXIMAL FEMUR PLATE. ATTEMPTS TO ENGAGE A SECOND RING PLATE ALSO FAILED, RESULTING IN THE INABILITY TO IMPLANT ANY RING PLATE. THE EVENT LED TO A SIGNIFICANT DELAY OF APPROXIMATELY 25 MINUTES, AND THE FRACTURE COULD NOT BE FIXED AS REQUIRED. THERE WAS REPORTED PATIENT HARM, BUT NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113895 ↗MalfunctionJan 14, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PFFX GREATER TROCH ATTACHMENT PLATES WERE NOT SCREWING INTO PLATE. USER TRIED SEVERAL ATTACHMENTS AND SEVERAL PLATES. USER THOUGHT THERE WAS AN ISSUE WITH ONE OF THE ATTACHMENT PLATE SCREWS WHICH THEN DEFORMED SOME PLATES. DOCTOR PROCEEDED WITH SURGERY WITHOUT ATTACHMENT PLATE. SURGERY WAS DELAYED BY 10 MINUTES DUE TO REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE NOT GENERATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21148442 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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