PRECICE® STRYDE System PS11.5-80D265Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887517951250), received between Oct 21, 2019 and Jul 26, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (3 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 18, 2026.

Recalls naming this device

1. Oct 29, 2021Class IIOpen, 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, 2021Class IIOpen, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Corroded; Material Discolored; Physical Resistance/Sticking; Corroded; Material Discolored; Physical Resistance/Sticking

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED, DETAILING THE EXAMINATION OF THE RETRIEVED IMPLANT. DURING THE ASSESSMENT, IT WAS NOTED THAT THE IMPLANT WAS UNABLE TO BE DISTRACTED AND RETRACTED AND FAILED THE FORCE TESTING. ADDITIONALLY, SURFACE DAMAGE GRADING REVEALED NOTABLE CORROSION, SCRATCHING, GALLING, SURFACE DEPOSITS AND DISCOLORATION. THE REPORT INDICATED THAT THE ROD WAS REMOVED AS PART OF A PLANNED PROCEDURE FOLLOWING THE ACHIEVEMENT OF THE DESIRED LENGTHENING. THE PATIENT HAD PREVIOUSLY REPORTED EXPERIENCING SIGNIFICANT THIGH PAIN, AND RADIOGRAPHIC OBSERVATIONS IDENTIFIED CORTICAL THICKENING AT THE EXTENDABLE JUNCTION OF THE NAIL.

  Patient problems: Implant Pain

  MAUDE report 19838940 ↗
• InjuryJun 9, 2021Break; Break

  INFORMATION WAS RECEIVED THAT THE NAIL WAS BROKEN AND THE PATIENT EXPERIENCED A SUDDEN ONSET OF PAIN. THE SURGEON BELIEVES THIS MAY BE ATTRIBUTED TO NON-UNION.

  Patient problems: Pain

  MAUDE report 11969816 ↗
• MalfunctionMar 16, 2021Material Discolored; Material Discolored

  IT WAS REPORTED THAT UPON REMOVAL OF THE NAIL AFTER IT HAD ACHIEVED ITS INTENDED PURPOSE AND OUTCOME, THERE WAS RUST NOTED ON THE JUNCTION OF THE NAIL. NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499318 ↗
• MalfunctionMar 16, 2021Material Discolored; Material Discolored

  IT WAS REPORTED THAT UPON REMOVAL OF THE NAIL AFTER IT HAD ACHIEVED ITS INTENDED PURPOSE AND OUTCOME, THERE WAS RUST NOTED ON THE JUNCTION OF THE NAIL. NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499287 ↗
• InjuryDec 17, 2020Fracture; Fracture

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER THE NAIL WAS FOUND TO BE FRACTURED DURING A FOLLOW UP APPOINTMENT. DESIRED LENGTHENING WAS ACHIEVED; HOWEVER, THERE WAS DELAYED HEALING AND THE BROKEN NAIL WAS EXCHANGED FOR A TRAUMA NAIL.

  Patient problems: Failure of Implant

  MAUDE report 11033913 ↗
• MalfunctionOct 21, 2019Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. AS PER REPORTER, THE NAIL STOPPED LENGTHENING AFTER 65 MM OF DISTRACTION.

  Patient problems: Failure of Implant

  MAUDE report 9216533 ↗