TRIGEN 71674523Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556363249), received between May 27, 2020 and May 7, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Separation Failure

  IT WAS REPORTED THAT, DURING A ORIF HIP INTERTAN SURGERY, TWO (2) INTERTAN 3.2MM GUIDE PIN SLEEVE AND TWO (2) LAG SCREW DRILL SLEEVE WERE COMPLETELY STUCK AND COULD NOT BE SEPARATED. ALSO, ONE (1) LAG SCREW LENGTH GAUGE WOULD NOT UNSCREW FROM THE LAG CAPTURE, THIS COMPLETELY STRIPPED THE AG SCREW LENGTH GAUGE AND ONE (1) LAG SCREW DRIVER. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112159 ↗
• MalfunctionDec 29, 2025Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A HIP NAIL SURGERY, THE LAG SCREW DRILL SLEEVE MIGHT BE BENT. IT WAS NOT TARGETING THE NAIL PROPERLY. PROCEDURE WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915439 ↗
• MalfunctionJan 13, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY. THE INTERTAN 3.2MM GUIIDE PIN SLEEVE WAS DAMAGED WHEN IT BECAME STUCK IN THE SLEEVE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY GREATER THAN 30 MINUTES. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13251654 ↗
• MalfunctionMay 31, 2021Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE INTERTAN 3.2MM GUIIDE PIN SLEEVE AND THE LAG SCREW DRILL SLEEVE WERE BENT AND HAD TO BE REMOVED FROM EACH OTHER WITH A MALLET. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909204 ↗
• MalfunctionMay 20, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, IT WAS NOTICED THAT THE FOLLOWING INSTRUMENTS OF THE TRIGEN¿ INTERTAN¿ INSTRUMENT SET ARE WARPED DUE TO WEAR AND TEAR OVER PAST 3 YEARS: LAG SCREW DRILL SLEEVE ((B)(4)), INTERTAN 3.2MM GUIIDE PIN SLEEVE ((B)(4)), LAG SCREW TAP ((B)(4)), LAG SCREW DRIVER ((B)(4)), COMPRESSION SCREW HEXDRIVER ((B)(4)), SUBTROC LAG SCREW DRIVER ((B)(4)), 130 RAD DRILL GDE DROP ((B)(4)), UNKNOWN TRIGEN INSTRUMENT ((B)(4)), UNKNOWN TRIGEN INSTRUMENT ((B)(4)). THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS GREATER THAN 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853757 ↗
• MalfunctionMay 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LAG SCREW DRILL SLEEVE AND THE INTERTAN 3.2MM GUIDE PIN SLEEVE ARE STICKING TOGETHER, SO THEY WON'T SLIDE PROPERLY. NO INJURY TO THE PATIENT REPORTED. IS IT UNKNOWN HOW THE PROCEDURE WAS FINISHED, WHEN THE EVENT OCCUR AND IF THERE WAS A DELAY. 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

  MAUDE report 11820389 ↗
• InjuryMar 15, 2021Connection Problem; Material Twisted/Bent; Connection Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE INTERTAN 3.2MM GUIIDE PIN SLEEVE AND LAG SCREW DRILL SLEEVE WERE NOTICED TO NO FIT TOGETHER EASILY DURING SURGERY AND INTERTAN 3.2MM GUIIDE PIN SLEEVE WAS INSERTED ON INCORRECT ANGLE. LAG SCREW DRILL SLEEVE WOULD ALSO NOT PASS THROUGH NAIL PROPERLY AND SURGEON HAD TO FREE HAND DRILL WITHOUT THE USE OF GUIDE. IT IS SUSPECTED THAT THE LAG SCREW DRILL SLEEVE WAS BENT AT SOME POINT. 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

  MAUDE report 11479246 ↗
• InjuryFeb 1, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING INTRAMEDULLARY NAILING SURGERY, THE LAG DRILL SLEEVE WOULD NOT GO THROUGH THE 130 DROP. THEN, THE SURGEON CHANGED TO A SMITH & NEPHEW 125 DROP. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND USING THE 125 DROP DEVICE. NO OTHER COMPLICATIONS WHERE REPORTED. 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

  MAUDE report 11256896 ↗
• MalfunctionJan 27, 2021Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT, A LAG SCREW DRILL SLEEVE WAS POPPING OUT OF DROPS IN THE JIG. INCIDENT OCCURRED DURING USE WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11235505 ↗
• MalfunctionJan 20, 2021Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT, A LAG SCREW DRILL SLEEVE WAS POPPING OUT OF DROPS IN THE JIG. INCIDENT OCCURRED DURING USE WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205393 ↗
• MalfunctionNov 18, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING INSPECTION, LAG SCREW DRILL SLEEVE GUIDE PIN SLEEVE DOES NOT SLIDE WELL/EASILY. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10864951 ↗
• InjuryNov 5, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE LAG SCREW DRILL SLEEVE WAS EXTREMELY DIFFICULT TO REMOVE FROM THE 3.2 GUIDE PIN SLEEVE DURING SURGERY. THE SURGEON HAD TO USE OTHER TOOLS TO REMOVE IT PRIOR TO DRILLING WITH THE LAG SCREW DRILL. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED. 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 10795793 ↗
• MalfunctionNov 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN INTERTAN NAILING, THE GUIDE PIN SLEEVE WAS BINDING INSIDE OF THE LAG SCREW DRILL SLEEVE. THIS OCCURRED DURING SURGERY. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. DELAY FROM 0 TO 30 MINUTES WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10789330 ↗
• InjuryNov 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE 3.2 GUIDE PIN SLEEVE WAS DIFFICULT TO REMOVE FROM THE LAG SCREW DRILL SLEEVE DURING SURGERY. THE SURGEON HAD DIFFICULTY REMOVING IT AND HAD TO USE OTHER INSTRUMENTATION TO PULL IT OUT. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10788797 ↗
• MalfunctionAug 26, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT METAL IS WARPED AND PIN FAILS TO INSERT AND REMOVE PROPERLY ON A LAG SCREW DRILL SLEEVE. UNKNOWN IF PATIENT INVOLVED. UNKNOWN PROCEDURE. PROCEDURE FINISHED WITH SAME DEVICE. UNKNOWN IF THERE WAS A BACKUP S&N DEVICE. DELAY GREATER THAN 30 MINUTES.

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

  MAUDE report 10457564 ↗
• InjuryMay 27, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET UP FOR SURGERY THE BEARING ON THE GUIDE PIN SLEEVE AND/OR THE LAG SCREW DRILL SLEEVE ISN'T WORKING PROPERLY. THE PIN SLEEVE WOULD NOT SLIDE INTO THE DRILL SLEEVE WITHOUT HEAVY MALLETING AND UNNEEDED EXTRA EFFORT. THERE WAS A DELAY LESS THAN 30 MINUTES. NO INJURY REPORTED. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10094399 ↗

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