TRIGEN 71631066Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 03596010478443), received between Jun 4, 2020 and Jun 7, 2026 — classified as 8 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) MEDIUM HEXDRIVER BROKE. THE PARTS WERE ALL ACCOUNTED FOR AND DISPOSED OF BY HOSPITAL STAFF. 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 25422607 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) MEDIUM HEXDRIVER BROKE IN THE THREADED HEAD OF A SCREW WHILE THREADING IT IN THE SCREW HOLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25343055 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT, DURING A NAIL EXTRACTION SURGERY, ONE (1) MEDIUM HEXDRIVER BROKE. NO PARTS FELL INTO THE PATIENT'S WOUND. 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 25145200 ↗
• InjuryFeb 21, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTRAMURALLY NAIL PROCEDURE, THE FIRST LOCKING SCREW WAS INSERTED, BUT WHEN ATTEMPTING TO INSERT THE SECOND LOCKING SCREW, IT BECAME EVIDENT THAT THE MEDIUM HEXDRIVER WAS NOT ENGAGING OR SECURING THE SCREW FOR PLACEMENT. THE TIP OF THE SCREWDRIVER WAS THEN OBSERVED TO BE FRACTURED, AND AN X-RAY REVEALED THE REMAINING PORTION OF THE SCREW THREAD EMBEDDED IN THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE THE PIECE, BUT IT WAS DECIDED TO LEAVE IT IN PLACE DUE TO THE PATIENT'S OBESITY. THE BROKEN PIECE OF THE HEX DRIVER REMAINED INSIDE THE PATIENT'S WOUND. IT WAS NOT POSSIBLE TO REMOVE IT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. PATIENT'S CURRENT HEALTH STATUS IS STABLE AS THERE WERE NO ADDITIONAL COMPLICATIONS AS THE PIECE WAS A MINIMAL PART AND DOES NOT POSE ANY RISK. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 24410379 ↗
• MalfunctionJan 7, 2026Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE RETENTION ROD OF THE MEDIUM HEXDRIVER SNAPPED OFF DISTALLY. NO FRAGMENTATION OCCURRED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996189 ↗
• MalfunctionNov 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY NAILING PROCEDURE, WHILE ATTEMPTING TO UNSCREW THE THREADED GUIDE, THE TIP OF THE MEDIUM HEXDRIVER BROKE. THE TIP WAS REMOVED USING A DRILL. THE BROKEN PIECES WERE COMPLETELY REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657104 ↗
• MalfunctionOct 28, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A FEMORAL RETROGRADE NAILING PROCEDURE, THE MEDIUM HEXDRIVER BROKE WHILE INSERTING THE DISTAL SCREW OF THE FEMORAL RETROGRADE NAIL. FRAGMENTS WERE REMOVED WITH RAT TOOTH FORCEPS. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, ALTHOUGH, IT IS UNKNOWN HOW WAS FINISHED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404463 ↗
• MalfunctionJul 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION, THE CAPTURE THREADS OF ONE MEDIUM HEXDRIVER BROKE INSIDE THE SCREW HEAD. THE BROKEN PIECE WAS RECOVERED USING A TONSIL. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT SURGICAL 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 22628399 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN OSTEOSYNTHESIS SURGERY, WHILE ATTEMPTING TO INSERT THE PROXIMAL LOCKING SCREW, IT FRACTURED, CAUSING ONE (1) MEDIUM HEXDRIVER TO DETACH FROM THE SCREW HEAD. THE SCREW WAS REMOVED, AND THE TIP OF THE SCREWDRIVER WAS OBSERVED TO BE STUCK IN PLACE. MANUAL REMOVAL WAS ATTEMPTED, FOLLOWED BY THE USE OF A POWERED HANDPIECE. NOTHING FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22392119 ↗
• MalfunctionJun 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN ADJUSTING THE LOCKING BOLT, THE CORE OF ONE (1) MEDIUM HEXDRIVER BROKE RIGHT AT THE JUNCTION OF THE SCREWDRIVER AND THE SCREW. 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 22208231 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, THE TIP OF MEDIUM HEXDRIVER BROKE. 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 22024808 ↗
• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) MEDIUM HEXDRIVER SHEARED OFF, WHILE USING THE INSTRUMENT IN THE PATIENT. NO PIECES FELL INSIDE THE PATIENT'S ANATOMY. IT WAS CHECKED ON X-RAYS. PIECES WERE RETRIEVED WITH TWEEZERS, FROM NEXT TO THE SCREW AS IT WAS INSERTED INTO THE PLATE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896375 ↗
• InjuryFeb 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE TIP OF THE THREADED INTERNAL ROD OF A (1) MEDIUM HEXDRIVER SNAPPED OFF. IT WAS LEFT INTO THE SCREW IN THE PATIENT, BECAUSE IT WAS THREADED INTO THE SCREW AND COULD NOT BE REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. THE PATIENT IS RECOVERING WELL.

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

  MAUDE report 21341203 ↗
• MalfunctionJan 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA CASE, THE DISTAL END OF A MEDIUM HEXDRIVER WAS NOTICED TO BE STRIPPED/SHEARED OFF. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125289 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT, DURING METANAIL TIBIA PROCEDURE, THE CATCH FOR SCREWS OF A MEDIUM HEXDRIVER BROKE. 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 21091895 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHILE USING A MEDIUM HEXDRIVER TO INSERT A SCREW IN A TIBIAL NAIL, ITS RETENTION ROD FRACTURED UPON REMOVAL. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE 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 20028002 ↗
• MalfunctionAug 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY (RETROGRADE NAIL PLANNED REMOVAL), THE HEAD OF ONE (1) MEDIUM HEXDRIVER BROKE WHILE ATTEMPTING TO REMOVE THE SCREWS FROM THE PATIENT. IT BROKE INTO 2 PIECES. THE VERY TIP OF THE HEX BROKE AWAY FROM THE SHAFT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006231 ↗
• MalfunctionJul 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRIGEN RETROGRADE NAILING, THE CAPTURE MECHANISM TIP OF A MEDIUM HEXDRIVER SNAPPED AND WAS RETRIEVED USING TWEEZERS. 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 19689337 ↗
• MalfunctionApr 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) MEDIUM HEXDRIVER BROKE. 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 19012582 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE WRENCH OF A LAG SCREW LENGTH GAUGE AND THE CAPTURE OF A MEDIUM HEXDRIVER WERE CHIPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE AND A SCREW WAS REMOVED WITHOUT CAPTURE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875442 ↗
• MalfunctionMar 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TIBIAL OSTEOSTOMY, WHEN TIGHTENING THE MEDIUM HEXDRIVER SCREW THE KEY BROKE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827515 ↗
• InjuryJan 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF THE MEDIUM HEXDRIVER BROKE AN REMAINS INSIDE THE SCREW HEAD IN THE PATIENT BODY. THERE IS NO PLAN TO ADDITIONAL SURGERY TO REMOVE THE PIECE AS THE PATIENT IS OLD. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18450207 ↗
• MalfunctionDec 11, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE MEDIUM HEXDRIVER IS BROKEN, THE ROD IS STUCK. 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 18301288 ↗
• MalfunctionOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A FEMUR FRACTURE PROCEDURE, THE KEY WAS LOOSE FROM THE MEDIUM HEXDRIVER, AS THE CAPTURE KEY INSIDE THE HEXAGONAL KEY HAD BROKEN. THE BROKEN KEY WAS REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034667 ↗
• MalfunctionSep 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION THE TIP OF A MEDIUM HEXDRIVER BROKE OFF WHILE IN THE PATIENT LEAVING METAL PIECES INSIDE THE PATIENT. ALL PIECES WERE REMOVED WITH CURVED METS AND BY HAND. THIS WAS VERIFIED BY FLUOROSCOPY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 17741152 ↗

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