NA 03.221.250Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982277015), received between Jul 19, 2022 and May 21, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break; Material Deformation

  IT WAS REPORTED THAT THERE WERE MULTIPLE ITEMS THAT WERE WARPED OR BROKEN AT THE FACILITY. THERE WAS NO HARM TO THE PATIENT AND NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240815 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE FOR THE HOOK PLATE CANNOT BE SCREWED INTO THE DESIGNATED HOLE ¿ IT DOESN'T ENGAGE THE THREAD. THERE WAS A SURGICAL DELAY OF THREE MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498348 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSERTION HANDLE FOR THE PPFX PLATING SYSTEM WOULD NOT THREAD INTO PLATES. AS WELL AS MESSED UP THREADS ON PLATE. IT WAS NOT KNOWN IF FRAGMENTS WERE GENERATED. IT WAS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646308 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON JULY 28, 2025, THE SURGEON ATTEMPTED TO IMPLANT A VA PPFX 8 HOLE HOOK PLATE WITH AN INSERTION HANDLE. AFTER A FEW MINUTES, SURGEON STATED THAT THE INSERTION HANDLE WOULD NOT THREAD INTO THE HOOK PLATE. HE USED A SECOND INSERTION HANDLE. AFTER A FEW MORE MINUTES, THE SURGEON STATED THAT THE SECOND INSERTION HANDLE ALSO WOULD NOT THREAD INTO THE HOOK PLATE. SURGEON CLOSELY EXAMINED ALL THREE ITEMS AND STATED ALL THREE WERE CROSS THREADED. SURGEON USED A BALL SPIKE PUSHER TO IMPLANT A SECOND VA PPFX 8 HOLE HOOK PLATE. OUTCOME OF CASE WAS GOOD. ESTIMATED DELAY OF FINISHING THE CASE WAS 10-15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785560 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON ATTEMPTED TO IMPLANT A VA PPFX 8 HOLE HOOK PLATE WITH AN INSERTION HANDLE. AFTER A FEW MINUTES, SURGEON STATED THAT THE INSERTION HANDLE WOULD NOT THREAD INTO THE HOOK PLATE. HE USED A SECOND INSERTION HANDLE. AFTER A FEW MORE MINUTES, THE SURGEON STATED THAT THE SECOND INSERTION HANDLE ALSO WOULD NOT THREAD INTO THE HOOK PLATE. SURGEON CLOSELY EXAMINED ALL THREE ITEMS AND STATED ALL THREE WERE CROSS THREADED. SURGEON USED A BALL SPIKE PUSHER TO IMPLANT A SECOND VA PPFX 8 HOLE HOOK PLATE. OUTCOME OF CASE WAS GOOD. ESTIMATED DELAY OF FINISHING THE CASE WAS 10-15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785524 ↗
• MalfunctionApr 23, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY WHEN THE IMPACTOR WAS TRIED TO ATTACH TO THE PLATE, BUT IT WOULD NOT ENGAGE. FURTHER INSPECTION SHOWED THAT THE THREADS ON THE IMPACTOR ARE WORN AWAY. THERE WAS A TWO (2) MINUTES OF SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895657 ↗
• MalfunctionApr 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE INSERTER WOULD NOT GET INTO PLATE. THIS HAPPENED BEFORE CASE WAS STARTED, SO NO PATIENT WAS INVOLVED. REPLACEMENT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885209 ↗
• MalfunctionMar 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, THE INSTRUMENT WAS BROKEN AND WORN. THE PATIENT WAS NOT AFFECTED BY THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503198 ↗
• MalfunctionJun 20, 2023Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2023 AT HOSPITAL, WHILE TRAINING ANOTHER REPRESENTATIVE, HE NOTICED THAT THE IMPACTION HANDLE FOR THE PPFX HOOK PLATE WAS DIFFICULT TO GET SCREWED INTO A PLATE. ANOTHER IMPACTION HANDLE WAS USED TO TEST AND IT WAS ABLE TO SCREW INTO THE PLATES BETTER, BUT SOME OF THE PLATES WERE A LITTLE ROUGHER THAN OTHERS. THE IMPACTOR WAS STILL ABLE TO SCREW IN ALL THE WAY THROUGH. THE ORIGINAL IMPACTOR WAS PULLED OUT. NO PATIENT INVOLVEMENT WAS THERE. THIS REPORT IS FOR ONE (1) INSERT HANDLE F/VA-LCP PPFX PROXIMAL FEM THIS IS REPORT 1 OF 2 FOR COMPLAINT. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162637 ↗
• MalfunctionJun 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2023 AT HOSPITAL, WHILE TRAINING ANOTHER REPRESENTATIVE, HE NOTICED THAT THE IMPACTION HANDLE FOR THE PPFX HOOK PLATE WAS DIFFICULT TO GET SCREWED INTO A PLATE. ANOTHER IMPACTION HANDLE WAS USED TO TEST AND IT WAS ABLE TO SCREW INTO THE PLATES BETTER, BUT SOME OF THE PLATES WERE A LITTLE ROUGHER THAN OTHERS. THE IMPACTOR WAS STILL ABLE TO SCREW IN ALL THE WAY THROUGH. THE ORIGINAL IMPACTOR WAS PULLED OUT. NO PATIENT INVOLVEMENT WAS THERE. THIS REPORT IS FOR ONE (1)UNK - HANDLES: TRAUMA THIS IS REPORT 2 OF 2 FOR COMPLAINT. (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162633 ↗
• MalfunctionJul 19, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE SURGERY, THE INSTRUMENT DID NOT WORK WELL. DURING THE FIRST ASSEMBLY OM THE PLATE, THERE WAS NO ISSUE. AFTER A FEW TIMES, THERE WAS NO PROPER CONNECTION BETWEEN THE PLATE AND SCREWDRIVER. THE SCREW WIRE WAS DAMAGED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) INSERTN HANDLE F/VA PPFX PROX FEMUR HOOK PL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051478 ↗