TRIGEN 71655032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010585462), received between Mar 26, 2020 and Dec 13, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A RIGHT TIBIAL IMN FIXATION SURGERY WITH ANTIBIOTIC SPACER PLACEMENT PERFORMED ON (B)(6) 2018 DUE TO INFECTED EXTERNAL FIXATOR, THE PATIENT SUSTAINED A RECALCITRANT FRACTURE SITE NONUNION WHICH REQUIRED INTRAMEDULLARY NAIL EXCHANGE WITH POSTERIO-LATERAL BONE GRAFTING ON (B)(6) 2020. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20924564 ↗
• MalfunctionSep 22, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, WHEN GOING TO PLACE THE DISTAL SCREWS OF THE META-NAIL TIBIAL 8.5MM X 32CM WITH THE SURESHOT, THE DRILL TOUCHED THE NAIL. AFTER SEVERAL TRIES, THEY MOVED THE PROBE TO THE CALIBRATION OF A 33CM (8.2X33) NAIL AND IT WORKED CORRECTLY. THE SURGEON SUSPECTS A PACKAGING PROBLEM, INSIDE THE BOX THERE WAS ACTUALLY AN 8.5X33 NAIL INSTEAD OF AN 8.5X32, AS THE BOX AND LABEL SAY. THE MATERIAL WILL NOT BE RETURNED SINCE IT HAS BEEN IMPLANTED AT PATIENT. THE SURGERY WAS COMPLETED AFTER A SIGNIFICANT DELAY. THE SURGICAL RESULT WAS GOOD, BUT THE SURGEON WAS NOT SATISFIED WITH THE EXTRA TIME IN THE SURGERY TO BE ABLE TO PLACE THE DISTAL SCREWS. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796603 ↗
• MalfunctionMar 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY THE TIBIA NAIL PLACEMENT WAS PERFORMED RETROGRADELY WITH AN ENTRY POINT IN THE CALCANEUS, SURE SHOT TECHNIQUE WAS PERFORMED FOR PLACEMENT OF TWO PROXIMAL LOCKING SCREWS, AND PLACEMENT OF TWO DISTAL SCREWS WITH DIRECTIONAL ARM AT THE CALCANEUS LEVEL. THE SPECIALIST DECIDED TO PLACE THE TIBIA NAIL OF 8.5 320 MM BECAUSE WHEN PERFORMING THE CORRECTIVE OSTEOTOMIES IN THE TIBIA AT THE DISTAL AND DIAPHYSEAL LEVEL, THE HIND FOOT NAIL DID NOT COVER THE LENGTH REQUIRED FOR FIXATION. THE SURGERY WAS FINISH USING AN ALTERNATE TECHNIQUE. NO ADVERSE EVENTS OR HEALTH PROBLEMS HAVE OCCURRED TO THE PATIENT. THERE WAS A DELAY BELOW 30 MINUTES AND NO BACKUP DEVICE WAS NECESSARY TO FINISH THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886436 ↗