PRECICE® STRYDE System PS11.5-80D280Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517951267), received between Jul 17, 2020 and Oct 13, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2021Corroded; Corroded

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Osteolysis; Pain

  MAUDE report 12628450 ↗
• MalfunctionDec 9, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. AS PER THE REPORTER, THE NAIL WAS NOT FUNCTIONING AND HAD TO BE EXCHANGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10979284 ↗
• MalfunctionDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE UPDATED INFORMATION IN H2, H3, H6 AND H10.

  Patient problems: Pain

  MAUDE report 10956355 ↗
• InjuryAug 4, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER REPORTER, THE NAIL STOPPED LENGTHENING SOMETIME BETWEEN (B)(6) AND (B)(6). NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10365815 ↗
• InjuryJul 17, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. THE PATIENT HAD A NAIL BREAK EARLIER THIS YEAR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10292098 ↗