TRIGEN 71631626Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 03596010529107), received between Feb 16, 2019 and Mar 2, 2026 — classified as 1 injury, 59 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (49 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, BEFORE A TIBIAL INTERNAL FIXATION, UPON OPENING THE STERILE PACKAGING OF THE 3MMX1000MM BALL TP GDE RD, THE SALES REP NOTICED THERE WAS A HOLE IN THE PAPER COMPONENT OF THE PACKAGE, RENDERING THE PART UNSTERILE AND UNSUITABLE FOR USE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK-UP PRODUCT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480034 ↗
• MalfunctionOct 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE AN INTERNAL FIXATION SURGERY, WHEN OPENING THE IMPLANTS, A HOLE WAS NOTICED ON THE STERILE PACKAGING OF A 3MMX1000MM BALL TP GDE RD. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410703 ↗
• MalfunctionAug 22, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, ONE (1) 3MMX1000MM BALL TP GDE RD PUNCTURED THROUGH STERILE PACK. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873531 ↗
• MalfunctionAug 22, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, ONE (1) 3MMX1000MM BALL TP GDE RD PUNCTURED THROUGH STERILE PACK AND THE BOX TOO. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873517 ↗
• MalfunctionDec 2, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING THE SET UP AND INSPECTION FOR AN ORIF SURGERY, IT WAS NOTICED THAT ONE (1) 3MMX1000MM BALL TP GDE RD HAD A HOLE IN THE PACKAGING. THE PROCEDURE WAS PERFORMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE. THE INCIDENT OCCURRED BEFORE THE PROCEDURE, SO THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819003 ↗
• MalfunctionNov 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP FOR A TRIGEN NAIL SURGERY, IT WAS NOTICED THAT THE PACKAGING OF TWO (2) 3MMX1000MM BALL TP GDE RD SEEMS PERFORATED-IT LOOKS LIKE THE CAP TO PROTECT THE SEAL HAS COME OFF. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706102 ↗
• MalfunctionOct 31, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING SET UP FOR AN INTERNAL FIXATION SURGERY, THE 3MMX1000MM BALL TP GDE RD'S PACKAGE WAS NOTICED TO HAVE A HOLE IN IT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577873 ↗
• MalfunctionOct 14, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE WIRES OF A 3MMX1000MM BALL TP GDE RD HAVE PUNCTURED THROUGH PLASTIC PROTECTIVE ENDS AND PIERCED STERILE PACKAGING AND BOX, UNAWARE OF WHERE THIS HAS OCCURRED, WAREHOUSE, TRANSPORT OR HOSPITAL. UNABLE TO USE. A S&N BACKUP DEVICE WAS AVAILABLE. SINCE THIS WAS NOTICED DURING SET UP OR INSPECTION, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440607 ↗
• MalfunctionOct 14, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE WIRES OF A 3MMX1000MM BALL TP GDE RD HAVE PUNCTURED THROUGH PLASTIC PROTECTIVE ENDS AND PIERCED STERILE PACKAGING AND BOX, UNAWARE OF WHERE THIS HAS OCCURRED, WAREHOUSE, TRANSPORT OR HOSPITAL. UNABLE TO USE. A S&N BACKUP DEVICE WAS AVAILABLE. SINCE THIS WAS NOTICED DURING SET UP OR INSPECTION, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440525 ↗
• MalfunctionAug 1, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING SET-UP FOR AN INTERTAN PROCEDURE, WHEN OPENING DISPOSABLES NURSE IDENTIFIED THAT THE 3MMX1000MM BALL TP GDE RD HAD A HOLE IN THE STERILE PACKAGING. THIS WAS IDENTIFIED PRIOR TO GIVING TO SCRUB NURSE, SO WAS JUST HANDED OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. AS THIS HAPPENED BEFORE SURGERY, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19885711 ↗
• MalfunctionJul 2, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING SET-UP FOR A NAIL PROCEDURE, ONE (1) 3MMX1000MM BALL TP GDE RD WAS NOTICED TO HAVE A HOLE IN THE INNER PACKAGING. THE PROCEDURE WAS PERFORMED USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653741 ↗
• MalfunctionJun 24, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHILE SETTING-UP FOR AN INTERNAL FIXATION SURGERY, AFTER OPENING THE OUTER BOX OF THE 3MMX1000MM BALL TP GDE RD, A HOLE IN THE INNER PACKAGING WAS NOTICED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601336 ↗
• MalfunctionMar 18, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A TIBIAL INTERNAL FIXATION, UPON OPENING THE OUTER BOX OF A 3MMX1000MM BALL TP GDE RD, THE STERILE PACKAGING WAS NOTED TO BE COMPROMISED, AS THE WIRE WAS POKING OUT. THE PROCEDURE WAS RESUMED AFTER 40 MIN USING A COMPETITOR´S DEVICE. HOWEVER, DUE TO THIS, THE PROCEDURE REQUIRED CAREFUL NAIL LENGTH CALCULATION, DUE TO THE DIFFERENCE OF DIMENSIONS BETWEEN THE CORRECT AND AVAILABLE GUIDEWIRES, POTENTIAL FOR PATIENT INJURY IF NAIL INSERTED WAS INCORRECTLY CALCULATED AND TOO LONG. CALCULATION GUIDANCE WAS REQUESTED FROM MANAGEMENT BUT WAS NOT RECEIVED. NO FURTHER CONSEQUENCES REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927236 ↗
• MalfunctionJan 9, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ONE (1) 3MMX1000MM BALL TP GDE RD WAS STICKING OUT OF THE STERILE WRAPPING AND THE BOX. PACKAGING WAS DAMAGED WITH HOLE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474492 ↗
• MalfunctionDec 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET-UP ACTIVITIES FOR AN INTERNAL FIXATION SURGERY, THE GLUE ON THE PACKAGING OF THE 3MMX1000MM BALL TP GDE RD WAS NOT INTACT, SO THE PRODUCT WAS NOT STERILE WHEN NURSE WENT TO OPEN THE ITEM. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393692 ↗
• MalfunctionDec 11, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, THERE WAS A HOLE IN THE STERILE PACKAGING OF A 3MMX1000MM BALL TP GDE RD. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302517 ↗
• MalfunctionDec 1, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING SET UP FOR TRAUMA SURGERY, WHILE OPENING ONE (1) 3MMX1000MM BALL TP GDE RD IT WAS NOTICED THAT THERE WAS A SMALL HOLE IN THE PACKAGE ON THE FOLD. IT LOOKS AS IF THE TIP OF THE WIRE HAS PERFORATED THE STERILE PACKAGING. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252274 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A HOLE WAS FOUND IN STERILE PACKAGING OF A 3MMX1000MM BALL TP GDE RD, BALL TIP WASN¿T SECURE IN SAFETY FOAM. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141312 ↗
• MalfunctionOct 30, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, A 3MMX1000MM BALL TP GDE RD HAD PIERCED THROUGH PACKAGING AND IT WAS UNSTERILE AND UNABLE TO BE USED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035952 ↗
• MalfunctionOct 30, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, THE 3MMX1000MM BALL TP GDE RDS PIERCED THROUGH THE PACKAGING, DEEMING THEM UNSTERILE AND UNUSABLE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035027 ↗
• MalfunctionOct 30, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, THE 3MMX1000MM BALL TP GDE RDS PIERCED THROUGH THE PACKAGING, DEEMING THEM UNSTERILE AND UNUSABLE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034989 ↗
• MalfunctionOct 30, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A 3MMX1000MM BALL TP GDE RD HAD GONE THROUGH THE PLASTIC STOPPER AND THROUGH THE STERILE PACKAGING, MAKING IT UN-USEABLE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034828 ↗
• MalfunctionOct 22, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHILE SETTING UP AN INTERNAL FIXATION SURGERY, WHEN THE BOX OF A 3MMX1000MM BALL TP GDE RD WAS OPENED, IT WAS NOTICED THAT THE GUIDE WIRE HAD PIERCED THE STERILE PACKAGING. IT APPEARS THAT THE PLASTIC BUSH/CAP THAT IS NORMALLY ON THE END OF THE GUIDE WIRE WAS NOT IN PLACE, THIS CAUSED THE WIRE TO POKE THRU. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY WITH A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982420 ↗
• MalfunctionOct 16, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A HOLE WAS FOUND ON THE STERILE PACKAGING OF A 3MMX1000MM BALL TP GDE RD. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940823 ↗
• MalfunctionOct 13, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SURGERY, WHEN OPENING THE BOX OF ONE (1) 3MMX1000MM BALL TP GDE RD, IT WAS FOUND THE ROD WAS STICKING THROUGH THE STERILE PACKAGE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936303 ↗