NA 2274-06-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295109044), received between Dec 28, 2018 and Aug 25, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SCREWDRIVER WAS ROUNDED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292687 ↗
• MalfunctionAug 25, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SCREWDRIVER WAS ROUNDED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292679 ↗
• MalfunctionAug 25, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SCREWDRIVER WAS ROUNDED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292670 ↗
• MalfunctionAug 25, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SCREWDRIVER WAS ROUNDED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292644 ↗
• MalfunctionAug 25, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SCREWDRIVER WAS ROUNDED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292628 ↗
• MalfunctionAug 25, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SCREWDRIVER WAS ROUNDED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292602 ↗
• MalfunctionOct 30, 2020Corroded; Corroded

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. BEFORE THE SURGERY, THE HOSPITAL STERILIZED THE SCREWDRIVER SHAFT AND TRIED TO OPEN THE PACKAGE, THE HOSPITAL STAFF FOUND THAT SOME BLACK LIQUID LIKE CORROSION ADHERED TO THE STERILIZED PACKAGE OF THE SCREWDRIVER SHAFT. THE HOSPITAL HAD BACKUP DEVICE WHICH WAS NOT STERILIZED, THEY STERILIZE THE BACKUP DEVICE AND STAGGERED TIME OF ONSET OF THE SURGERY, AND THE PATIENT COULD UNDERGO THE SURGERY ON THE DAY. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763630 ↗
• MalfunctionJan 7, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CORNER OF THE TIP OF THE SCREWDRIVER WAS ROUNDED AFTER THE SURGEON USED WITH A STRONG FORCE, AND THE SCREWDRIVER DID NOT FIT WELL TO SCREWS DURING THE TKA SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8223164 ↗
• MalfunctionDec 28, 2018Material Deformation; Material Deformation

  ROUTINE INSPECTION INDICATED DAMAGED ITEMS NEEDED REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202785 ↗