TRIGEN 71631189Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010445681), received between Mar 30, 2021 and Nov 6, 2024 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K093047); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE TIP OF ONE (1) SCREW DEPTH GAUGE WAS BROKEN. THE PROCEDURE WAS RESUMED, 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 20620370 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE SCREW DEPTH GAUGE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 18393680 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING CPD, A SCREW DEPTH GAUGE WAS FOUND BROKEN, NO SURGERY INVOLVED. 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 15535489 ↗
• MalfunctionJun 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, A SCREW DEPTH GAUGE HAS MISSING INNER PARTS. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778074 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT, TWO (2) SCREW DEPTH GAUGE WERE BROKEN. 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 14140719 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT A SCREW DEPTH GAUGE IS PRESENTING PROBLEMS AND IT IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13213761 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT, A SCREW DEPTH GAUGE WAS BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164331 ↗
• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, SCREW DEPTH GAUGE BROKE OUTSIDE 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 12076740 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT ONE (1) SCREW DEPTH GAUGE AND ONE (1) RULER ARE BROKEN AND FADING. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053408 ↗
• MalfunctionJun 1, 2021Break; Break

  IT WAS REPORTED THAT THE NEEDLE OF A SCREW DEPTH GAUGE WAS NOTICED TO BE BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916483 ↗
• InjuryMay 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING A IM NAIL, THE T-HANDLE SNAPPED IN HALF ((B)(4)), THE T7 HOLDING SLEEVE NO LONGER CAPTURES (B)(4), AND THE SCREW DEPTH GAUGE BROKE (B)(4) INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITH A DELAY OF FEWER THAN 30 MINUTES USING A S&N BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779917 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT DURING A SCREW SURGERY, A SCREW DEPTH GAUGE BROKE OUTSIDE OF THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS COMPLETED WITH A SMITH & NEPHEW BACK UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704447 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT WHEN PUTTING TRACK TOGETHER OF THE SCREW DEPTH GAUGE (AFTER WASH) THE DEVICE BROKE. NO CASE INVOLVED THEREFORE NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704446 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT WHEN PUTTING TRACK TOGETHER OF THE SCREW DEPTH GAUGE (AFTER WASH) THE DEVICE BROKE. NO CASE INVOLVED THEREFORE NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704445 ↗
• InjuryApr 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, IT WAS NOTICED THAT THE TIP OF THE SCREW DEPTH GAUGE WAS BENT/BROKEN OFF AND SO AN ACCURATE DEPTH WAS NOT ABLE TO BE OBTAINED USING THIS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A COMPETITOR'S DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627511 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS REPORTED THAT THREE UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), THE TIBIAL SPACER BLOCK STANDARD ((B)(4)) THE JOURNEY II XR TIBIAL BASE IMPLANT IMPACTOR ((B)(4)) AND THE JOURNEY UNI TIBIAL TRAIL INSERT SIZE 3-4/ 9 MM ((B)(4)) WERE NOTICED CRACKED. THE SCREW DEPTH GAUGE ((B)(4)), META-TAN ANTI ROTATION BAR ((B)(4)), HUMERAL RULER ((B)(4)), TWO SCREW DRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) THE JOURNEY II TKA FEMORAL TRIAL LEFT SIZE 5 ((B)(4)) AND 3.5 MM LOCKING SCREW GUIDE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593499 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434