TRIGEN 71654502Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010585837), received between Jul 1, 2020 and Oct 15, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionOct 15, 2025Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  IT WAS REPORTED THAT, DURING A RETROGRADE NAIL SURGERY, IT WAS NOTICED THAT ONE (1) STD DRILL GUIDE BROKE OFF. NO PIECES FELL INSIDE THE PATIENT THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303548 ↗
• MalfunctionMar 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE OF THE PRONGS OF A STD DRILL GUIDE FELL OFF WHEN IMPACTING THE TIBIAL NAIL. IT IS UNKNOWN IF THIS CAUSED A DELAY IN SURGERY AND HOW SURGERY WAS CONTINUED. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645611 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT DURING A NAIL SURGERY, THE STD DRILL GUIDE BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192483 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A TRIGEN STANDARD DRILL GUIDE BROKE, NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544863 ↗
• InjurySep 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION A STD DRILL GUIDE BROKE WHILE INSERTING NAIL. SURGERY WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE, WITH 5 MINUTE OF SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542698 ↗
• MalfunctionJun 22, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING CPD A TRIGEN STANDARD DRILL GUIDE WAS NOT ABLE TO CONNECT TO THE ANTERIOR DROP. 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 12042905 ↗
• MalfunctionJun 8, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE SURGEON STATED THAT IT WAS DIFFICULT TO LINE UP PROPERLY A GUIDE BOLT (CASE: (B)(6)) AND A STD DRILL GUIDE (CASE: (B)(6)) DURING THE CASE. A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES OCCURRED DUE TO THIS ISSUE, AND A SMITH AND NEPHEW BACKUP DEVICES WERE AVAILABLE TO CONCLUDE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962531 ↗
• InjuryMay 21, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY THE NAILS DID NOT LOCK INTO THE STD DRILL GUIDE BECAUSE THE TIP OF THE GUIDE WAS CHIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863549 ↗
• MalfunctionMay 7, 2021Fitting Problem; Material Twisted/Bent; Fitting Problem; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER SURGERY THE STANDARD DRILL GUIDE PEG WAS BENT MAKING IT DIFFICULT TO LOCK INTO THE ANTERIOR DROP. THE SURGERY WAS MADE WITH THE SAME DEVICE. NO INJURY OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794614 ↗
• InjuryApr 6, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AFTER TKA PROCEDURE, IT WAS FOUND THAT THE STANDARD DRILL GUIDE IS STICKING WHILE TAKING APART. THE DRILL GUIDE WAS VERY HARD TO REMOVE FROM THE AIMING GUIDE. THERE WAS NO CASE NOR PATIENT INVOLVED WHEN THE ISSUE WAS IDENTIFIED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624910 ↗
• MalfunctionMar 25, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, WHEN THE STD DRILL GUIDE WAS BEING USED TO PUT THE TIBIAL NAIL INTO THE BODY. THE SURGEON DISTALLY LOCKED FIRST AND THEN USED BACK SLAPPING TECHNIQUE TO COMPRESS THE FRACTURE, IN THE PROCESS THE GUIDE BEND AND DID NOT OPERATE PROPERLY. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30MIN USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572438 ↗
• MalfunctionDec 29, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT AFTER PROCEDURE, IT WAS NOTICED THAT THE STANDARD DRILL GUIDE WOULD NOT FIT INTO THE ANTERIOR DROP. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087751 ↗
• MalfunctionOct 6, 2020Break; Break

  IT WAS REPORTED THAT DURING THE CASE (INSTRUMENT OUTSIDE THE PATIENT) THE DRILL GUIDE FOR THE JIG BROKE, ONE OF THE THREE PRONGS ON THE BOTTOM CAME OUT ENTIRELY AND LEFT THE JIG UNSTABLE. THE BROKEN PIECE HAS SINCE BEEN PUT BACK IN THE DRILL GUIDE, BUT IT IS NOT IN THE CORRECT POSITION. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10636446 ↗
• InjurySep 16, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SURGEON WAS PERFORMING A TIBIAL NAIL AND HIT THE IMPACTOR, THE TEETH OF THE DRILL GUIDE WAS BROKE. ALL PIECES WERE RECOVERED. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN AND THE SURGERY WAS FINISH USING A BACKUP FROM SMITH&NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME AND DID NOT BLAME THE DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10543714 ↗
• MalfunctionAug 26, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE STD DRILL GUIDE FOR THE META RETROGRADE NAIL WOULD NOT ALLOW THE NAIL TO SIT FLUSH, IT WAS NOTICED A NOTCH IN ONE OF THE ATTACHMENTS THAT SNAPS INTO CARBON JIG. THIS HAPPENED DURING USE OUTSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10457257 ↗
• MalfunctionJul 9, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING THE INSPECTION THE DRILL GUIDE DO NOT CLIP IN PROPERLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10254490 ↗
• MalfunctionJul 1, 2020Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT DURING A META NAIL CASE THE LONG PIECE THAT FITS INTO ANTERIOR DROP IS WARPED AND WILL NOT SEAT. NO DELAY REPORTED. PROCEDURE WAS FINISHED WITH S+N BACKUP DEVICE. NO INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10217742 ↗

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