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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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 ↗

Other Plate, fixation, bone devices

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Sources and updates

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