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NA 02.221.100Recalls & reported problems

Synthes GmbH · 3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982275998), received between Apr 25, 2023 and May 12, 2026 — classified as 1 injury, 6 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 18, 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: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 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: 1 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 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/Bent3
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Hematoma1
  • Insufficient Information1
  • Unspecified Infection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 12, 2026Device-Device Incompatibility

    IT WAS REPORTED ON (B)(6) 2026, DURING THE SURGERY, ON THE SCRUB TABLE, THE SURGICAL TECHNICIAN WAS AFFIXING A GREATER TROCHANTER RING ATTACHMENT PLATE TO A PERIPROSTHETIC PROXIMAL FEMUR PLATE WHEN THE ATTACHMENT BOLT BECAME LODGED IN THE RECEIVING THREADS. THE BOLT WAS UNABLE TO ACHIEVE PROPER TORQUE AS IT FELL SHORT OF DEPTH, THEN REQUIRED PLIERS TO GET THE TWO PIECES APART. THERE WAS NO KNOWLEDGE OR EVIDENCE THAT EITHER IMPLANT HAD BEEN CONNECTED BEFORE THIS INSTANCE. NO SURGERY DELAYED DUE TO THE REPORTED EVENT. A DIFFERENT PLATE WAS USED. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25148613 ↗
  • MalfunctionJan 22, 2026Material Twisted/Bent

    IT WAS REPORTED THAT VA LOCKING PPFX GREATER TROCHANTER RING AND 3.5 VAL GREAT TROCH RNG ATCH PL/LRG/RT AND 3.5 VAL GREAT TROCH RING ATTACH PL/SM/LT WERE INVOLVED IN AN EVENT. DURING A PROCEDURE TO REPAIR A FRACTURE AROUND A TOTAL HIP, ATTEMPTS TO ATTACH THE SMALL GT RING ATTACHMENT PLATE TO THE VA-LCP PPFX PROXIMAL FEMUR PLATE WERE UNSUCCESSFUL DUE TO STRIPPED SCREWS ON THE GT RING ATTACHMENT. FURTHER ATTEMPTS TO REMOVE SCREWS FROM THE LARGE GT RING PLATE ALSO RESULTED IN STRIPPED SCREWS. ALL SCREWS FROM THE GT RING PLATES (FOUR IN TOTAL) WERE FOUND TO BE STRIPPED, PREVENTING ATTACHMENT. THE PROCEDURE WAS COMPLETED WITHOUT THE GT RING ATTACHMENT PLATE, RESULTING IN A DELAY OF APPROXIMATELY 10 MINUTES. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE, AND THE PATIENT OUTCOME WAS GOOD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24143851 ↗
  • MalfunctionNov 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON NOVEMBER 4, 2025 THAT THE CONNECTING SCREW FOR GREATER TROCH ATTACHMENT DID NOT LOCK INTO THE PROXIMAL FEMUR PLATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23606870 ↗
  • MalfunctionDec 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    IT WAS REPORTED THAT THE SALES REP WAS DOING A DEMO WITH A SURGEON, SHOWING HIM OUR VA PPFX SYSTEM. THE SALES REP ATTACHED THE GREATER TROCHANTER RING PLATE ONTO A PROXIMAL FEMUR PLATE AS A DEMONSTRATION. AT THE END OF THE DEMO WHEN REP WENT TO DISASSEMBLE THE TWO PLATES, THE T15 RECESS ON THE CONNECTING SCREW OF THE GREATER TROCHANTER RING PLATE STRIPPED. THE REP WAS UNABLE TO SEPARATE THE TWO PLATES NOW. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20857126 ↗
  • InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 13 PATIENTS THAT WERE IMPLANTED WITH VA-LCP PERIPROSTHETIC PROXIMAL FEMUR PLATING SYSTEM. IMPLANTATION WAS BETWEEN (B)(6) 2021 TO (B)(6) 2024 AT UNIVERSITY HOSPITAL CLEVELAND. ALL PATIENTS HAD THE IMPLANTS PLACED FOR TREATMENT OF PROXIMAL PERIPROSTHETIC FEMUR FRACTURES. PATIENT ID #(B)(6) (70-YEAR-OLD FEMALE) ¿ REQUIRED SURGICAL DEBRIDEMENT 4 WEEKS POST OPERATION DUE TO INFECTION SECONDARY TO A HEMATOMA AFTER ANTI-COAGULATION THERAPY. NO IMPLANTS WERE REMOVED. THE PATIENT WENT ON TO ACHIEVE BONE UNION AT FINAL FOLLOW UP AND WAS AMBULATORY WITH A CANE. THE HEMATOMA AND INFECTION WERE NOTED TO BE RELATED TO THE PROCEDURE. THIS REPORT IS FOR A 3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT.

    Patient problems: Hematoma; Unspecified Infection

    MAUDE report 20169205 ↗
  • MalfunctionSep 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS FAILED TO CONNECT DURING SURGERY, FORCING SURGEONS TO USE DIFFERENT PLATE. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE 3.5 VAL GREAT TROCHRING ATTACH PL/SM/RT. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 20137364 ↗
  • MalfunctionApr 25, 2023Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2023 DURING ORIF OF RIGHT FEMUR UPON CONNECTING RING ATTACHMENT PLATE TO THE PROXIMAL FEMUR PLATE, THE CONNECTING SCREW ON THE RING ATTACHMENT STRIPPED AND WAS NOT ABLE TO BE DISCONNECTED. THE APPROPRIATE TORQUE LIMITING DRIVER WAS UTILIZED. ANOTHER PLATE AND RING ATTACHMENT WERE CHOSEN AND UTILIZED FOR THE CASE WITH NO ISSUES, DELAYS OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16808643 ↗

Other Plate, fixation, bone devices

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Sources and updates

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