PRECICE® STRYDE System PS10.0-80B265Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517950765), received between Oct 26, 2020 and Jul 27, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT THE NAIL WAS REVISED DUE TO OSTEOLYSIS OBSERVED VIA X-RAY. IN ADDITION, PICTURES PROVIDED BY THE SURGEON REVEAL CORROSION ON THE NAIL.

  Patient problems: Osteolysis

  MAUDE report 12232686 ↗
• MalfunctionJul 21, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT THE PATIENT REPORTED PAIN. ADDITIONALLY, IT WAS REPORTED THAT UPON EXPLANT THE NAIL WAS NOTED TO HAVE RUST.

  Patient problems: Pain

  MAUDE report 12207204 ↗
• MalfunctionJan 25, 2021Break; Break

  NO ADDITIONAL EVENT INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11228123 ↗
• MalfunctionOct 26, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT POST SURGICAL REVIEW, THE STRYDE FEMUR NAIL WAS FOUND TO BE RETRACTED VIA X-RAY. THE SURGEON ORDERED ANOTHER 2 WEEKS OF DISTRACTION AND THE NAIL WAS FOUND UNABLE TO HOLD THE DISTRACTED LENGTH. NO PATIENT INJURY WAS REPORTED. EXCHANGE OF THE NAIL IS PLANNED FOR AN UNKNOWN DATE.

  Patient problems: Failure of Implant

  MAUDE report 10738473 ↗