TRIGEN 71631436Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556158371), received between Mar 13, 2021 and Jun 1, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K122170); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Fracture; Use of Device Problem

  IT WAS REPORTED THAT, DURING A META-TAN SURGERY, THE SURGICAL TEAM REPORTED THAT THE SYSTEM OF ONE (1) META-TAN DROP, ONE (1) META-TAN LAG SCREW DRILL SLEEVE AND ONE (1) META-TAN GUIDE PIN SLEEVE WAS MISALIGN, AS THEY INSERTED A GUIDE WIRE (GUIDE PIN 3.2MM X 343MM) AND WHEN THEY SCREWED THE CANNULATED LAG SCREW OVER THE WIRE, THE WIRE SNAPPED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347671 ↗
• MalfunctionMar 11, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, BEFORE AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT UPON OPENING THE BOX OF TWO (2) GUIDE PIN 3.2MM X 343MM PRESENTED WITH VERY SMALL HOLES IN THE PAPER SIDE OF THE STERILE PACKAGING, LOCATED NEAR THE SHARP TIP OF THE WIRE. IT WAS PRESUMED THAT THE WIRE TIP PUNCTURED THE STERILE BARRIER AS THE PACKAGING PAPER WAS FOLDED OVER IT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568548 ↗
• MalfunctionApr 4, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE STERILE PACKAGE OF A GUIDE PIN 3.2MM X 343MM WAS FOUND UNSEALED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 16678550 ↗
• MalfunctionMar 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE AN INTERTAN NAIL PROCEDURE, A GUIDE PIN 3.2MM X 343MM WAS REMOVED FROM THE OUTER BOX PACKAGING AND INSIDE THE STERILE POUCH WAS SEEN TO HAVE A HOLE FROM THE SHARP END OF GUIDE WIRE. THIS MAKES THE ITEM UNSTERILE AND STAFF WAS NOT HAPPY TO USE IT. 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 16483391 ↗
• MalfunctionSep 16, 2021Contamination; Contamination

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN OPENING THE BOX OF A GUIDE PIN 3.2MM X 343MM IT WAS FOUND THAT THERE WERE TWO PIECES OF PAPER (LID) OVERLAPPING. SURGERY WAS COMPLETED WITH THE SAME DEVICE WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485547 ↗
• InjuryJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, AFTER INSERTING THE GUIDE PIN 3.2MM X 343MM FOR AN INTERTAN NAIL, THE SURGEON NOTICED THAT THE GUIDE PIN WAS BENT. THE PHYSICIAN INSERTED ANOTHER GUIDE PIN 3.2MM X 343MM WHICH ALSO BENT. THERE WERE EXTRA PIN HOLES IN THE FEMORAL HEAD AS A RESULT OF THE PINS BENDING AND THE SURGEON HAD TO ACCOMMODATE FOR THE BENDING GUIDE WIRES, THE HOLES WERE NOT TREATED. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO DELAY REPORTED. THE PATIENT'S OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation

  MAUDE report 12011307 ↗
• InjuryJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, AFTER INSERTING THE GUIDE PIN 3.2 MM X 343 MM FOR AN INTERTAN NAIL, THE SURGEON NOTICED THAT THE GUIDE PIN WAS BENT. THE PHYSICIAN INSERTED ANOTHER GUIDE PIN 3.2 MM X 343 MM WHICH ALSO BENT. THERE WERE EXTRA PIN HOLES IN THE FEMORAL HEAD AS A RESULT OF THE PINS BENDING AND THE SURGEON HAD TO ACCOMMODATE FOR THE BENDING GUIDE WIRES, THE HOLES WERE NOT TREATED. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO DELAY REPORTED. THE PATIENT'S OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation

  MAUDE report 12011194 ↗
• InjuryJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING INTRAMEDULLARY NAILING FIXATION OF AN INTERTROCHANTERIC HIP FRACTURE, A TOTAL OF 5 GUIDE PIN 3.2 MM X 343 MM WERE NOTICED TO BE TOO SOFT AND DEFORMABLE. THIS ISSUE, CONFIRMED BY X-RAYS WHEN THE ANTI-ROTATION BAR WAS INSERTED AND WAS NOTICED TO BE CONTACTING THE TIP OF THE GUIDE PIN IN THE FEMORAL HEAD, LED TO THE INTRAMEDULLARY NAIL MIGRATING PROXIMALLY AND THE GUIDE PIN BENDING DURING DRILLING WITH THE COMPRESSION STARTER DRILL AND LATER ON WITH THE COMPRESSION DRILL. BECAUSE OF THIS, IT WAS NECESSARY TO REMOVE AND REPOSITION BOTH THE LAG AND COMPRESSION SCREWS. A SURGICAL DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO THIS EVENT, BUT IT IS UNKNOWN IF THE PROCEDURE WAS CONCLUDED WITH THE SAME GUIDE PINS OR WITH BACKUP GUIDE PINS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hip Fracture

  MAUDE report 12010976 ↗
• InjuryJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING INTRAMEDULLARY NAILING FIXATION OF AN INTERTROCHANTERIC HIP FRACTURE, A TOTAL OF 5 GUIDE PIN 3.2MM X 343MM WERE NOTICED TO BE TOO SOFT AND DEFORMABLE. THIS ISSUE, CONFIRMED BY X-RAYS WHEN THE ANTI-ROTATION BAR WAS INSERTED AND WAS NOTICED TO BE CONTACTING THE TIP OF THE GUIDE PIN IN THE FEMORAL HEAD, LED TO THE INTRAMEDULLARY NAIL MIGRATING PROXIMALLY AND THE GUIDE PIN BENDING DURING DRILLING WITH THE COMPRESSION STARTER DRILL AND LATER ON WITH THE COMPRESSION DRILL. BECAUSE OF THIS, IT WAS NECESSARY TO REMOVE AND REPOSITION BOTH THE LAG AND COMPRESSION SCREWS. A SURGICAL DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO THIS EVENT, BUT IT IS UNKNOWN IF THE PROCEDURE WAS CONCLUDED WITH THE SAME GUIDE PINS OR WITH BACKUP GUIDE PINS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hip Fracture

  MAUDE report 12010860 ↗
• InjuryJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING INTRAMEDULLARY NAILING FIXATION OF AN INTERTROCHANTERIC HIP FRACTURE, A TOTAL OF 5 GUIDE PIN 3.2 MM X 343 MM WERE NOTICED TO BE TOO SOFT AND DEFORMABLE. THIS ISSUE, CONFIRMED BY X-RAYS WHEN THE ANTI-ROTATION BAR WAS INSERTED AND WAS NOTICED TO BE CONTACTING THE TIP OF THE GUIDE PIN IN THE FEMORAL HEAD, LED TO THE INTRAMEDULLARY NAIL MIGRATING PROXIMALLY AND THE GUIDE PIN BENDING DURING DRILLING WITH THE COMPRESSION STARTER DRILL AND LATER ON WITH THE COMPRESSION DRILL. BECAUSE OF THIS, IT WAS NECESSARY TO REMOVE AND REPOSITION BOTH THE LAG AND COMPRESSION SCREWS. A SURGICAL DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO THIS EVENT, BUT IT IS UNKNOWN IF THE PROCEDURE WAS CONCLUDED WITH THE SAME GUIDE PINS OR WITH BACKUP GUIDE PINS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hip Fracture

  MAUDE report 12010748 ↗
• InjuryJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING INTRAMEDULLARY NAILING FIXATION OF AN INTERTROCHANTERIC HIP FRACTURE, A TOTAL OF 5 GUIDE PIN 3.2MM X 343MM WERE NOTICED TO BE TOO SOFT AND DEFORMABLE. THIS ISSUE, CONFIRMED BY X-RAYS WHEN THE ANTI-ROTATION BAR WAS INSERTED AND WAS NOTICED TO BE CONTACTING THE TIP OF THE GUIDE PIN IN THE FEMORAL HEAD, LED TO THE INTRAMEDULLARY NAIL MIGRATING PROXIMALLY AND THE GUIDE PIN BENDING DURING DRILLING WITH THE COMPRESSION STARTER DRILL AND LATER ON WITH THE COMPRESSION DRILL. BECAUSE OF THIS, IT WAS NECESSARY TO REMOVE AND REPOSITION BOTH THE LAG AND COMPRESSION SCREWS. A SURGICAL DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO THIS EVENT, BUT IT IS UNKNOWN IF THE PROCEDURE WAS CONCLUDED WITH THE SAME GUIDE PINS OR WITH BACKUP GUIDE PINS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hip Fracture

  MAUDE report 12010432 ↗
• InjuryJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING INTRAMEDULLARY NAILING FIXATION OF AN INTERTROCHANTERIC HIP FRACTURE, A TOTAL OF 5 GUIDE PIN 3.2 MM X 343 MM WERE NOTICED TO BE TOO SOFT AND DEFORMABLE. THIS ISSUE, CONFIRMED BY X-RAYS WHEN THE ANTI-ROTATION BAR WAS INSERTED AND WAS NOTICED TO BE CONTACTING THE TIP OF THE GUIDE PIN IN THE FEMORAL HEAD, LED TO THE INTRAMEDULLARY NAIL MIGRATING PROXIMALLY AND THE GUIDE PIN BENDING DURING DRILLING WITH THE COMPRESSION STARTER DRILL AND LATER ON WITH THE COMPRESSION DRILL. BECAUSE OF THIS, IT WAS NECESSARY TO REMOVE AND REPOSITION BOTH THE LAG AND COMPRESSION SCREWS. A SURGICAL DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO THIS EVENT, BUT IT IS UNKNOWN IF THE PROCEDURE WAS CONCLUDED WITH THE SAME GUIDE PINS OR WITH BACKUP GUIDE PINS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hip Fracture

  MAUDE report 12010414 ↗
• MalfunctionApr 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN IM NAILING OF PROXIMAL FEMUR FRACTURE, FOUR GUIDE PIN 3.2MM X 343MM WERE BENDING. ON OBTAINING ENTRY POINT FOR PROXIMAL REAMER, GUIDE WIRES INTRODUCED TO TIP OF GREATER TROCHANTER BY HAND AND BENT. CANNULATED ENTRY AWL WAS UTILISED TO ASSIST; HOWEVER, ONCE ENTRY REAMER WAS PASSED OVER THE GUIDE PIN, EACH GUIDE PIN BECAME BENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND HOW LONG WAS DELAYED AS CONSEQUENCE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617561 ↗
• MalfunctionApr 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN IM NAILING OF PROXIMAL FEMUR FRACTURE, FOUR GUIDE PIN 3.2MM X 343MM WERE BENDING. ON OBTAINING ENTRY POINT FOR PROXIMAL REAMER, GUIDE WIRES INTRODUCED TO TIP OF GREATER TROCHANTER BY HAND AND BENT. CANNULATED ENTRY AWL WAS UTILISED TO ASSIST; HOWEVER, ONCE ENTRY REAMER WAS PASSED OVER THE GUIDE PIN, EACH GUIDE PIN BECAME BENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND HOW LONG WAS DELAYED AS CONSEQUENCE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617560 ↗
• MalfunctionApr 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN IM NAILING OF PROXIMAL FEMUR FRACTURE, FOUR GUIDE PIN 3.2MM X 343MM WERE BENDING. ON OBTAINING ENTRY POINT FOR PROXIMAL REAMER, GUIDE WIRES INTRODUCED TO TIP OF GREATER TROCHANTER BY HAND AND BENT. CANNULATED ENTRY AWL WAS UTILISED TO ASSIST; HOWEVER, ONCE ENTRY REAMER WAS PASSED OVER THE GUIDE PIN, EACH GUIDE PIN BECAME BENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND HOW LONG WAS DELAYED AS CONSEQUENCE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617554 ↗
• MalfunctionApr 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN IM NAILING OF PROXIMAL FEMUR FRACTURE, FOUR GUIDE PIN 3.2MM X 343MM WERE BENDING. ON OBTAINING ENTRY POINT FOR PROXIMAL REAMER, GUIDE WIRES INTRODUCED TO TIP OF GREATER TROCHANTER BY HAND AND BENT. CANNULATED ENTRY AWL WAS UTILISED TO ASSIST; HOWEVER, ONCE ENTRY REAMER WAS PASSED OVER THE GUIDE PIN, EACH GUIDE PIN BECAME BENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND HOW LONG WAS DELAYED AS CONSEQUENCE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617552 ↗
• MalfunctionMar 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION A GUIDE PIN 3.2MM X 343MM WAS BENT WHEN IT WAS TAKEN OUT OF THE PACKAGE. THIS WAS REPORTED DURING INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478619 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha