LARGE CANNULATED SCREWS 71177131Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010601506), received between Oct 5, 2020 and Apr 6, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A TEARDROP HANDLE WITH LARGE AO BROKE. THE PROCEDURE WAS COMPLETED, WITH DELAY LESS THAN 30 MIN, USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021922 ↗
• MalfunctionJul 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING BONE FIXATION, A TEARDROP HANDLE WITH LARGE AO BROKE WHILE INSTRUMENTS WERE OUTSIDE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK UP DEVICE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132216 ↗
• MalfunctionMay 31, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURE, THE HANDLE OF A TEARDROP HANDLE WITH LARGE AO WOULD NOT DISENGAGE FROM THE DRIVER SHAFT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909245 ↗
• MalfunctionMay 13, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY, A 4.7MM BALL HEXDRIVER WAS STUCK INSIDE TEARDROP HANDLE WITH LARGE AO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822168 ↗
• MalfunctionApr 18, 2021Break; Break

  IT WAS REPORTED THAT HE CHUCK CAME APART AT THE SPRING. NO HARM OR DELAY WAS REPORTED. THE FAILURE WAS NOTICED DURING SET UP OR INSPECTION. SN BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683483 ↗
• MalfunctionJan 28, 2021Corroded; Corroded

  IT WAS REPORTED THAT RUST IS STARTING TO FORM ON THE END OF THE HANDLE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242590 ↗
• MalfunctionOct 5, 2020Break; Break

  IT WAS REPORTED THAT THE HANDLE OF THE TEARDROP HANDLE WITH LARGE AO WAS FOUND TO BE BROKEN. NO CASE RELATED THEREFORE NO PATIENT INVOLVED. 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 Patient Involvement

  MAUDE report 10632358 ↗

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