REFLECTION 71362294Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 03596010454195), received between May 13, 2020 and May 14, 2025 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) RATCHET HANDLE BROKE OFF WHILE IN USE. ALL PIECES WERE REMOVED AND ACCOUNTED. THERE WAS NO SURGICAL DELAY; HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019613 ↗
• MalfunctionDec 16, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE RATCHET HANDLE BROKE. IT IS UNKNOWN HOW SURGERY WAS RESUMED OR IF ANY DELAY OCCURRED. NO FURTHER INFORMATION AVAILABLE AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20948561 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE DIRECTIONAL LOCKING MECHANISM OF A RATCHET HANDLE BROKE WHILE TIGHTENING SCREW DURING THE CASE. ALL PIECES WERE ACCOUNTED FOR, PIECES DID NOT ENTERED 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 20563527 ↗
• MalfunctionSep 27, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THR SURGERY, THE TOP OF ONE (1) RATCHET HANDLE POPPED OFF (DETACHED) AND IT WAS UNABLE TO SNAP IT BACK IN. THE DEVICE WAS ALSO WORN. 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 20322287 ↗
• MalfunctionSep 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, A RATCHET HANDLE BROKE. THE PROCEDURE WAS COMPLETED WITHOUT 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 20224220 ↗
• MalfunctionDec 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT A SCREW OF A RATCHET HANDLE WAS MISSING, AND DEVICE WOULD NOT HOLD ON TO THE DRIVER SHAFT AT THE CONNECTION POINT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITORS DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18389800 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE RATCHETING PART OF THE RATCHET HANDLE BROKE DURING USE. 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 17698001 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, WHEN SETTING UP FOR A THR SURGERY, THE BALL BEARING OF THE RATCHET HANDLE FELL OUT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072327 ↗
• InjuryFeb 15, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A THE MECHANISM OF A REFLECTION RATCHET HANDLE CAME LOOSE AND BROKE OFF, ALL PIECES WERE RECOVERED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13537014 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT DURING THE SET UP FOR A THR, A RATCHET HANDLE WAS NOTICED TO BE BROKEN. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A SMITH AND NEPHEW BACK UP DEVICE. AS THIS WAS NOTICED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13532875 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT A RATCHET HANDLE IS BROKEN ON THE HANDLE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239768 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT THE SCREW ON PIECE FOR TOP PART OF RATCHET HANDLE IS BROKEN. AS THIS WAS NOTICED DURING SET UP, THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13181741 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE RATCHET HANDLE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY AS CONSEQUENCE OF THIS PROBLEM. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152286 ↗
• MalfunctionJan 3, 2022Break; Break

  IT WAS REPORTED THAT A RATCHET HANDLE WAS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142160 ↗
• MalfunctionDec 21, 2021Break; Break

  IT WAS REPORTED THAT A REFLECTION RATCHET HANDLE WAS BROKEN AFTER 1 MONTH OF PURCHASE. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNCLEAR, FOR WHICH PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056652 ↗
• MalfunctionOct 22, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A RATCHET HANDLE IS BROKEN AND HAS MECHANICAL JAMS. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683180 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT, A RATCHET HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616034 ↗
• MalfunctionOct 6, 2021Break; Break

  IT WAS REPORTED THAT A REFLECTION RATCHET HANDLE IS 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 12582765 ↗
• MalfunctionSep 10, 2021Break; Break

  IT WAS REPORTED THAT A REFLECTION RATCHET HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456549 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE RATCHET MECHANISM BROKE OFF FROM THE REFLECTION RATCHET HANDLE WHILE INSTRUMENTS WERE 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 12201267 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, A REFLECTION RATCHET HANDLE BROKE OFF 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 12201230 ↗
• MalfunctionJul 13, 2021Break; Connection Problem; Naturally Worn; Break; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, DURING THE SET UP OF A THR SURGERY, A REFLECTION RATCHET HANDLE WAS NOT ABLE TO CAPTURE BECAUSE IT IS WORN DUE TO EXCESSIVE USE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. HOWEVER, THE INVESTIGATION FOUND THAT A PIECE HAS BROKEN OFF THE HANDLE, WHICH MAKES THIS EVENT A REPORTABLE MALFUNCTION. 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 12163720 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A RATCHET HANDLE BROKE OFF, OUTSIDE OF THE PATIENT, NO PIECES FELL IN THE WOUND. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (LESS THAN 30 MIN), USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096818 ↗
• MalfunctionJun 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A RATCHET HANDLE BROKE OFF. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012512 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE MECHANISM OF A RATCHET HANDLE WAS BROKEN WHILE THE INSTRUMENT WAS HANDLED OUTSIDE THE PATIENT. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACKUP RATCHET HANDLE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968510 ↗

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