PRECICE® STRYDE System PS10.0-80SJ265Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517951601), received between Jul 9, 2020 and Oct 18, 2021 — classified as 4 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. 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 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THE NAIL PRECONSOLIDATED. THE NAIL WAS REMOVED ON AN UNKNOWN DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12651476 ↗
• InjuryMar 29, 2021Corroded; Corroded

  ADDITIONAL INFORMATION WAS RECEIVED VIA REVIEW OF LITERATURE THAT THE PATIENT EXPERIENCED OSTEOLYSIS AND PERIOSTEAL REACTION AT POSTOPERATIVE DAY 229; APPROXIMATELY 48 DAYS AFTER THE ONSET OF INITIAL SYMPTOMS OF PAIN.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 11586759 ↗
• InjuryFeb 16, 2021Material Discolored

  NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

  Patient problems: Inflammation; Pain

  MAUDE report 11336188 ↗
• InjuryJan 12, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11156990 ↗
• MalfunctionJul 9, 2020Defective Device; Defective Device

  SEE UPDATED INFORMATION IN D4, D10, H2, H3, H6 AND H10.

  Patient problems: Failure of Implant

  MAUDE report 10255475 ↗