PERSONA® 42-5171-009-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024238664), received between Mar 23, 2020 and Jan 30, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

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.

• MalfunctionJan 30, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610895 ↗
• MalfunctionOct 16, 2023Fracture; Fracture

  IT WAS REPORTED THE INSTRUMENT FRACTURED DURING THE PROCEDURE. NO PATIENT HARM WAS REPORTED. NO ADDTIONAL INFORMATION AVAILABLE FROM HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17944006 ↗
• MalfunctionAug 8, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480849 ↗
• MalfunctionJun 19, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154070 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15878562 ↗
• MalfunctionNov 1, 2021Separation Failure; Mechanical Jam; Separation Failure; Mechanical Jam

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728617 ↗
• MalfunctionMar 23, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED A TASP WAS RETURNED FRACTURED ON A WORN INSTRUMENT CLAIM FORM. ALL PIECES HAVE BEEN RETURNED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9866130 ↗