Modular Arthrodesis Nail CP260601Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304082984), received between Jan 20, 2021 and May 1, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K042409); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT UPON TIGHTENING THE ARTHRODESIS PERIMETER SCREW INTO PLACE DURING FINAL IMPLANTATION, THE SCREW HEAD BROKE OFF. ONCE THE SCREW HEAD BROKE OFF, THE PIECE WAS REMOVED. NO FOREIGN BODIES WERE RETAINED. THE BODY OF THE SCREW WAS LEFT IN PLACE AS THE SURGEON WAS UNABLE TO GET IT OUT TO REPLACE IT WITH A NEW ONE. THE SURFACE OF THE SCREW THAT WAS LEFT IN WAS NOT SITTING ABOVE THE COMPONENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221456 ↗
• MalfunctionNov 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT UPON TIGHTENING THE ARTHRODESIS PERIMETER SCREW INTO PLACE DURING FINAL IMPLANTATION, THE SCREW HEAD BROKE OFF. ONCE THE SCREW HEAD BROKE OFF, THE PIECE WAS REMOVED. NO FOREIGN BODIES WERE RETAINED. THE BODY OF THE SCREW WAS LEFT IN PLACE AS THE SURGEON WAS UNABLE TO GET IT OUT TO REPLACE IT WITH A NEW ONE. THE SURFACE OF THE SCREW THAT WAS LEFT IN WAS NOT SITTING ABOVE THE COMPONENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226416 ↗
• InjuryAug 31, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE CONNECTOR IS THE DEVICE THAT FRACTURED, NOT THE LOCKING COLLAR. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 12391349 ↗
• MalfunctionJan 20, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11202328 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042409. One submission often covers many models, so check the product and lot details in each record.

• Z-1036-2023 · Nov 29, 2022 · Open, Classified
  OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrode
• Z-1522-2018 · Apr 3, 2018 · Terminated
  Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including mids