TRAUMACEM 03.702.150SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982262233), received between Mar 7, 2018 and Nov 24, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (3 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT FOR AN ORTHOPEDIC SURGICAL PROCEDURE. THE AUGMENT WAS MIXED ACCORDING TO INSTRUCTIONS AND CANNULA WAS PREFILLED WITH 4ML OF AUGMENT AND STOPPED WHEN IT STARTED COMING OUT. WHEN THE SURGEON PUT THE CANNULA INTO THE SLEEVE INTO THE HELICAL BLADE TO INSERT THE AUGMENT, NOTHING WOULD COME OUT. THE SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF 7 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1); UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1); UNK - INSERTION INSTRUMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES THREE(3) DEVICES. THIS REPORT IS FOR (1) TRAUMACEM(TM) V+ SYRINGE KIT - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12871087 ↗
• MalfunctionSep 13, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, PATIENT UNDERWENT ORTHOPEDIC PROCEDURE. DURING A RIGHT FEMUR TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) INSERTION THE SURGEON REQUESTED TRAUMACEM. DURING THE PREPARATION OF THE TRAUMACEM, THE TECH HAD DIFFICULTY MIXING THE CEMENT, HE WAS UNABLE TO COMPRESS THE T HANDLE TO "FULLY COMPRESSED STOP" POSITION. THE CEMENT WAS DIFFICULT TO LOAD INTO THE SMALL SYRINGE AND THE DOCTOR WAS UNABLE TO INJECT THE CEMENT INTO THE TFNA LAG SCREW. SURGEON ABANDONED THE CEMENT IMPLANTATION. THERE WAS A (5) MINUTES OF SURGICAL DELAY NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) TRAUMACEM(TM) V+ SYRINGE KIT - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463598 ↗
• MalfunctionSep 9, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE TRAUMACEM V+ INJECTION CANNULA AND TRAUMACEM V+ SYRINGE KIT WOULD NOT INJECT INTO SYRINGES ONCE MIXED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508595 ↗
• InjuryMar 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORT THAT THE PATIENT UNDERWENT ORIGINAL SURGERY ON (B)(6) 2018 FOR TREATMENT OF A FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) TFNA TROCHANTERIC FIXATION NAIL ADVANCED, (1) HELICAL BLADE AND TWO (2) DISTAL LOCKING SCREWS. INTRAOPERATIVELY, AFTER THE NAIL HAD BEEN IMPLANTED, AT THE BACK TABLE, THAT SURGEON PREPARED THE TTAUMACEM V CEMENT. IT WAS REPORTED THAT THE INJECTOR WAS NOT FILLING THE SYRINGES INITIALLY. IT WOULD NOT TURN PROPERLY, AND THE HOLE WHERE THE STOP CONNECTS WAS TRAPPED. THE DOCTOR CLEARED THE HOLE, THAT WAS JAMMED, AND PMMA SLOWLY RELEASED INTO SYRINGES. BY THIS TIME THE VISCOSITY WAS TOO THICK TO SEND DOWN INJECTION CANNULA. SURGEON WAS UNABLE TO INJECT THE CEMENT MIX THROUGH TO THE HELICAL BLADE IMPLANT. SURGEON CHOSE NOT TO INCLUDE THE CEMENT MIX THAT WAS ORDINALLY PLANNED FOR IN THIS PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH 5-MINUTE TIME DELAY. PATIENT WAS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICE REPORTED: TRAUMACEM (TM) V+ INJECTION CANNULA FOR TFNA - STERILE (ITEM # 03.702.121S, LOT # AQY317, QUANTITY 1). THIS REPORT IS FOR ONE (1) TRAUMACEM(TM) V+ SYRINGE KIT - STERILE. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7321120 ↗