PRECICE® STRYDE System PS10.0-80B280Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517950772), received between Sep 26, 2019 and Mar 15, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Break; Break

  INFORMATION WAS RECEIVED THAT THE PATIENT HAD COMPLETED LENGTHENING AND CONSOLIDATION, WHEN IT WAS NOTED THAT AFTER EXPLANT, THE NAIL WAS BROKEN THROUGH THE DISTAL PROXIMAL SCREW. NO PATIENT ADVERSE EVENT WAS REPORTED.

  MAUDE report 13765644 ↗
• MalfunctionNov 16, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE NAIL FAILED TO DISTRACT INTRA-OPERATIVELY DURING AN IMPLANTATION PROCEDURE ON (B)(6) 2020. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10849303 ↗
• MalfunctionSep 26, 2019Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT ALLEGED THAT THE STRYDE NAIL'S DISTAL SCREW WAS BACKING OUT AND THE NAIL HAD SUB-OPTIMUM LENGTHENING. AS PER REPORTER, PATIENT CLAIMS TO BE NON-WEIGHT BEARING AND IS USING THE ERC PER SURGEON PRESCRIPTION.

  Patient problems: Failure of Implant

  MAUDE report 9123954 ↗