PRECICE® STRYDE System PS10.0-80D280Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517951199), received between Mar 30, 2020 and Mar 29, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Corroded” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 29, 2021Open, Classified

   The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

   Z-0319-2022 · Root cause: Device Design · FDA record ↗

2. Feb 12, 2021Open, Classified

   Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

   Z-1323-2021 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryMar 29, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT A REVISION WAS PERFORMED IN (B)(6) 2021 DUE TO X-RAY IMAGES REVEALING THAT THE PATIENT'S BONE WAS BREAKING DOWN. UPON EXPLANT, IT WAS NOTED THAT THE NAIL HAD CORROSION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Osteolysis; Pain

  MAUDE report 11586621 ↗
• InjuryFeb 23, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021. AS PER THE REPORTER, THE PATIENT COMPLAINED OF INCREASING PAIN IN THE FEMUR. X-RAYS CONFIRMED INFLAMMATION AND OSTEOLYSIS WHICH IS BELIEVED TO BE ATTRIBUTED TO LEAKAGE/SPILLAGE FROM THE NAIL.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 11369913 ↗
• InjurySep 28, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS COMPLETED ON (B)(6) 2020 AS THE NAIL WAS NOT LENGTHENING POST-OPERATIVELY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10597699 ↗
• MalfunctionMar 30, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT AN OSTEOTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, THE NAIL WAS NOT LENGTHENING IN THE LEFT LEG.

  Patient problems: Failure of Implant

  MAUDE report 9901015 ↗