TRIGEN 71631448Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556158319), received between Aug 3, 2020 and Mar 7, 2026 — classified as 6 injuries, 7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE END OF ONE (1) META-TAN COMP SCREW STARTER DRILL SNAPPED OFF. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. ALL THE BROKEN PIECES WERE REMOVED, ACCOUNTED AND THE PATIENT WAS X RAYED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541007 ↗
• MalfunctionJan 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE [1] META-TAN COMP SCREW STARTER DRILL BROKE OFF DURING USE, INSIDE THE SURGICAL FIELD. THE PROCEDURE WAS RESUMED, AFTER 20 MINUTES DELAY, WITH A S+N BACK-UP DEVICE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PIECES WERE RETRIEVED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277933 ↗
• MalfunctionMar 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF THE META-TAN COMP SCREW STARTER DRILL SNAPPED INTRAOPERATIVELY. THE TIP WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY, THE SURGEON MOVED TO THE NEXT STEP USING THE COMPRESSION DRILL AS THIS STEP HAD BEEN COMPLETED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956057 ↗
• MalfunctionJan 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE USING A META-TAN COMP SCREW STARTER DRILL, THE TIP OF THE DEVICE WAS DRILLING AGAINST THE NAIL AND BROKE OFF. VERIFICATIONS HAD BEEN PERFORMED TO ENSURE THAT THE PROSTHESIS WAS ATTACHED TO THE ALIGNMENT INSTRUMENT AND TARGETED CORRECTLY, EVERYTHING APPEARED TO BE FINE DURING AND AFTER INSERTION UNDER X-RAYS AND A TARGETED PRE-INSERTION WAS DONE TO CONFIRM EVERYTHING WAS ALIGNED FINE. A SECOND META-TAN COMP SCREW STARTER DRILL WAS OPENED AND THE SAME ISSUE OCCURRED. THE BROKEN DEVICE PIECE THAT FELL IN THE PATIENT'S WOUND WAS FOUND WITH X-RAYS AND REMOVED USING FORCEPS. NO PIECES OF THE BROKEN DEVICE WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY USING A 4 MM LONG DRILL BIT TO CREATE THE STARTER HOLE, THEN, THE LESSER OF THE TWO BROKEN COMP SCREW STARTER DRILLS WAS USED TO CREATE THE SIZE FOR THE COMPRESSION SCREW DRILL WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE AND THE SURGEONS SEEMED SATISFIED WITH THE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503515 ↗
• MalfunctionFeb 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAIL PROCEDURE, THE META-TAN COMP SCREW STARTER DRILL FRACTURED AT THE TIP WHILE SURGEON WAS TRYING TO DRILL PAST THE CLAMPS, HOLDING THE REDUCTION. NO PIECES FELL INTO THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325701 ↗
• InjuryNov 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TIP OF A META-TAN COMP SCREW STARTER DRILL BROKE WHILE IN USE INSIDE THE PATIENT. THE PIECE WAS LEFT IN THE PATIENT, CONSULTANTS DECISION AS THEY COULD NOT GET IT OUT. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME REPORTED DEVICE. IT IS UNKNOWN HOW THIS ISSUE IS BEING ADDRESSED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 15838240 ↗
• InjuryJun 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A META-TAN COMP SCREW STARTER DRILL BROKE DURING USE. THE PIECE WAS RETRIEVED. SURGERY WAS FINISHED AFTER A DELAY OF 30 MINUTES OR LESS, WITH A SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599402 ↗
• InjuryMar 29, 2022Break; Break

  IT WAS REPORTED THAT, AFTER SURGERY, IT WAS NOTICED THE META-TAN COMP SCREW STARTER DRILL HAD BROKEN OFF. AN IMAGING CONFIRMED THE PIECE REMAINS INSIDE THE PATIENT'S BODY. PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 13935443 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A META-TAN COMPRESSION SCREW STRAIGHTER DRILL BROKE, IT IS UNKNOWN IF ANY 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 12297553 ↗
• InjuryAug 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE COMPRESSION SCREW COULD NOT GO THROUGH THE NAIL. IT IS UNKNOWN WHETHER THE META-TAN DRILL GUIDE, THE META-TAN DROP, THE META-TAN COMP SCREW DRILL OR THE META-TAN COMP SCREW STARTER DRILL CAUSED THIS PROBLEM. A CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED TO COMPLETE THE PROCEDURE WITHOUT ANY DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271667 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT TIP OF A META-TAN COMP SCREW STARTER DRILL 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 12171060 ↗
• InjuryDec 22, 2020Break; Break

  IT WAS REPORTED THAT, THE TIP OF A META-TAN COMP SCREW STARTER DRILL SHEARED OFF. INCIDENT OCCURRED DURING PROCEDURE WITH INSTRUMENTS INSIDE THE PATIENT, THE TIP WAS RECOVERED AND DISPOSED OFF. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS OR EQUAL THAN 30 MIN, USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055055 ↗
• InjuryAug 3, 2020Break; Break

  IT WAS REPORTED THAT DURING MID SHAFT FEMUR FRACTURE PROCEDURE. IT WAS USED AS A METATAN PRODUCT TO RESOLVE THE PROBLEM, BUT THE COMPRESSION REAMER TIP BROKE OFF INSIDE OF THE PATIENT, BUT ALL PIECES WERE REMOVED. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. THE SURGERY WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE. 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 10357256 ↗

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