PRECICE® STRYDE System PS10.0-65SJ250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517951588), received between Dec 19, 2019 and Dec 15, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Defective Device” (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.

• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED A BONY FISTULA AT THE JUNCTION OF THE MALE/FEMALE PORT.

  Patient problems: Fistula

  MAUDE report 13011029 ↗
• InjuryApr 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION PROVIDED: "THE IMPLANT STILL WITH PATIENT, WE DON'T KNOW THAT HE WOULD RETURN TO US OR NOT." PATIENT OUTCOME WAS GOOD.

  Patient problems: Osteolysis

  MAUDE report 11741867 ↗
• InjuryDec 19, 2019Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2019. AS PER REPORTER, THE NAIL WAS UNABLE TO DISTRACT.

  Patient problems: Failure of Implant

  MAUDE report 9498359 ↗