TRIGEN 71631440Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00885556158340), received between May 29, 2020 and Mar 31, 2026 — classified as 19 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (26 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE RETAINING ROD INSIDE TWO (2) META-TAN LAG SCREW DRIVER WERE CHIPPED, THEREFORE, THE LAG SCREW IMPLANT WAS NOT ENGAGED PROPERLY AND THE SCREW CAME LOOSE, A GUIDE PIN HAD TO BE USED TO KEEP SOME TIME OF CONTACT WITH THE IMPLANT BEING INSERTED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750391 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE CAPTURE PIECE OF A META-TAN LAG SCREWDRIVER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850234 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A IMN FEMUR SURGERY, THE THREADS OF ONE (1) META-TAN LAG SCREWDRIVER BROKE DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638414 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE INNER THREADED SCREW OF ONE (1) META-TAN LAG SCREWDRIVER WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED AND IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23253928 ↗
• MalfunctionSep 16, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING NAIL REMOVAL CASE, CAPTURE THREADS OF TWO (2) META-TAN LAG SCREWDRIVER BROKE TRYING TO REMOVE A NAIL. NO BROKEN PIECES FELL INTO THE PATIENT. 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 23062817 ↗
• InjuryJul 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE END OF THE META-TAN LAG SCREWDRIVER ROD, BROKE OFF IN THE PATIENT. SURGEON LEFT THE BROKEN END OF THE DEVICE INSIDE THE PATIENT ON SCREW. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22602529 ↗
• MalfunctionJun 18, 2025Fracture; Sharp Edges; Fracture; Sharp Edges

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE RELEASING THE CAPTURE FROM THE SCREW WITH ONE (1) META-TAN LAG SCREWDRIVER; THE INSERT CHIPPED AND IS NOW SHARP. THE DEVICE FAILED LOOSENING THE CAPTURE OF THE DRIVER BECAUSE THE CAPTURE BENT AND CHIPPED WHILE USING THE LAG SCREW DEPTH GAUGE REMOVAL TOOL. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288684 ↗
• MalfunctionJun 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE META-TAN LAG SCREWDRIVER BENT AND BROKE DURING REMOVAL OF LAG SCREW. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THIS CAUSED A SURGICAL DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157580 ↗
• MalfunctionJun 2, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A NAIL REMOVAL SURGERY, ONE (1) META-TAN LAG SCREW DRIVER WAS USED AND THE END OF THIS DEVICE BROKE OFF. SURGERY COULD NOT BE FINISHED. THE NAIL BEING REMOVED WAS LEFT IN THE PATIENT, AND THE PATIENT WAS CLOSED UP. THE NAIL WAS GOING TO BE REMOVED BECAUSE THE PATIENT HAD AN ACCIDENT AND BENT THE NAIL. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124103 ↗
• MalfunctionMay 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, ONE (1) META-TAN LAG SCREW DRIVER CHIPPED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS A SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092762 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT A META-TAN LAG SCREW DRIVER BROKE TRYING TO REMOVE A LAG SCREW. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318343 ↗
• InjuryOct 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, A 41-YEAR-OLD FEMALE WITH POLY TRAUMA AFTER A ROAD TRAFFIC ACCIDENT, CAME TO OPERATING ROOM FOR OPEN REDUCTION AND INTERNAL FIXATION + INTRAMEDULAR NAILING ON LEFT FEMUR + OPEN REDUCTION AND INTERNAL FIXATION IN LEFT PATELLA + CLOSED REDUCTION AND INTERNAL FIXATION WITH K WIRE FIXATION ON RIGHT RADIUS UNDER GENERAL ANESTHESIA. DURING THIS INTERNAL FIXATION SURGERY, WHILE FIXATING THE NAIL, THE TIP OF A META-TAN LAG SCREWDRIVER SHAFT WAS BROKEN AND ATTACHED WITH THE INTERNAL HEX CAPTURED SCREW. SURGEONS TRIED TO REMOVE IT, BUT THEY COULD NOT. ACCORDING TO SURGEON IT WILL NOT HARM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20447125 ↗
• InjuryJul 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REMOVAL PROCEDURE OF A META-TAN NAIL, THE INNER ROD OF THE META-TAN LAG SCREW DRIVER WHICH WAS CONNECTED TO THE LAG SCREW BROKE OFF. THE PIECE REMAINS AT THE CONNECTION PART OF THE LAG SCREW. THE PROCEDURE WAS CANCELLED AND THE NAIL COULD NOT BE REMOVED. NO FURHTER COMPLICATIONS WERE REPORTED

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body Reaction

  MAUDE report 19740971 ↗
• InjuryJun 18, 2024Fracture; Misassembled; Fracture; Misassembled

  IT WAS REPORTED THAT, DURING A META TAN REMOVAL SURGERY, WHEN TRYING TO REMOVE THE LAG SCREW WITH A META-TAN LAG SCREW DRIVER, THE CONNECTION PART ON THE LAG SCREW WAS DEFORMED BY COMPRESSION. FURTHERMORE THE TIP OF THE INNER ROD WAS BROKEN OFF. THE PIECE COULD NOT BE RETRIEVED AND WAS LEFT INSIDE THE PATIENT. AFTER A NON-SIGNIFICANT DELAY, THE DOCTOR GAVE UP THE REMOVAL OF THE NAIL. NO ADDITIONAL SURGERY HAS BEEN SCHEDULED AT THE MOMENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19558897 ↗
• InjuryNov 8, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A META-TAN SCREW PLANNED REMOVAL, THE TIP OF A META-TAN LAG SCREW DRIVER BENT AND BROKE OFF. THE SURGEON FAILED TO REMOVE THE PIECE FROM THE PATIENT'S BODY. THE BACK END OF THE META-TAN LAG/COMP KIT 90/85 FRACTURED OFF AS WELL. AFTER A DELAY OF MORE THAN 30 MIN, THE SCREW AND DEVICE TIP COULD NOT BE REMOVED, BOTH REMAIN EMBEDDED IN THE PATIENT'S BONE. NO ADDITIONAL INTERVENTION IS PLANNED TO REMOVE THE BROKEN PIECE FROM HIS BODY. PATIENT'S CURRENT HEALTH STATUS IS GOOD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18095435 ↗
• MalfunctionDec 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE END OF THE CAPTURE OF THE META-TAN LAG SCREW DRIVER BROKE. 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. 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 16009703 ↗
• InjuryAug 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY OF NAIL REMOVAL (PLANNED SURGERY), WHEN REMOVING'S THE LAG SCREW, THE TIP OF THE TWO (2) META-TAN LAG SCREW DRIVER WERE BROKEN. USING OTHER TOOL SCREW EXTRACTOR SIZE 1, THE SURGERY WAS COMPLETED, BUT ALSO IT WAS BROKEN WHEN IT WAS REMOVED FROM THE EXPLANTED LAG SCREW. DEVICE INSIDE THE PATIENT. PIECES FELL INSIDE THE PATIENT AND IT IS UNKNOWN IF/HOW THE PIECES WERE EXTRACTED. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS 30 MIN DELAYED. PATIENT WAS NOT HARMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245747 ↗
• InjuryJun 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY OF NAIL REMOVAL (PLANNED SURGERY), WHEN REMOVING'S THE LAG SCREW, THE TIP OF THE TWO (2) META-TAN LAG SCREW DRIVER WERE BROKEN. DEVICE INSIDE THE PATIENT. PIECES FELL INSIDE THE PATIENT AND IT IS UNKNOWN IF/HOW THE PIECES WERE EXTRACTED. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS 30 MIN DELAYED. PATIENT WAS NOT HARMED. NO FURTHER INFORMATION IS AVAILABLE. 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 14852870 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN IM NAIL PROCEDURE, THE META-TAN LAG SCREW DRIVER RETENTION ROD BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655072 ↗
• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED THAT THE META-TAN LAG SCREW DRIVER WAS BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307732 ↗
• MalfunctionApr 25, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, A META-TAN LAG SCREW DRIVER IS STRIPPED. AS THIS WAS NOTICED IN A ON-SURGICAL ENVIRONMENT, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192407 ↗
• MalfunctionMar 23, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE THREADS OF A TRIGEN META-TAN LAG SCREW DRIVER ASSEMBLY STRIPPED WHEN TRYING TO REMOVE THE LAG SCREW. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866711 ↗
• MalfunctionFeb 7, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE META-TAN LAG SCREW DRIVER WAS BENT AND K-WIRE WOULD NOT GO THROUGH IT. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476904 ↗
• MalfunctionJan 4, 2022Flaked; Material Twisted/Bent; Naturally Worn; Flaked; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT A META-TAN LAG SCREW DRIVER IS WORN, FADED, CHIPPED AND BENT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152371 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE END OF THE RETAINING ROD FOR THE A META-TAN LAG SCREW DRIVER BROKE OFF. INCIDENT OCCURRED WITH INSTRUMENT OUTSIDE PATIENT. SURGERY WAS FINISHED WITH THE SAME DEVICE, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917173 ↗

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