PRECICE® STRYDE System PS10.0-80D265Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887517951182), received between Nov 20, 2020 and Feb 18, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WILL BE PERFORMED DUE TO A BROKEN NAIL BEING DISCOVERED VIA X-RAY.

  Patient problems: Failure of Implant

  MAUDE report 21403209 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED THAT A REMOVAL PROCEDURE WAS PERFORMED DUE TO TWO BROKEN FEMORAL NAILS. THE NAILS WERE DIFFICULT TO REMOVE FROM THE BONE, RESULTING IN REMOVAL OF ONLY THE SCREWS AND PROXIMAL PORTION OF THE NAILS. THE UNIVERSAL REMOVAL KIT WAS USED REMOVAL OF ALL PORTIONS OF THE NAIL WAS UNSUCCESSFUL. DUE TO THIS THE PATIENT'S PROCEDURE WAS PROLONGED.

  Patient problems: Failure of Implant

  MAUDE report 21355203 ↗
• MalfunctionApr 13, 2022Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE NAIL BREAKING. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104414 ↗
• MalfunctionNov 19, 2021Corroded; Corroded

  NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848916 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA REVIEW OF MEDICAL LITERATURE THAT A PATIENT HAD OSTEOLYSIS THE NAIL¿S TELESCOPIC JUNCTION AND REPORTED PAIN DURING DISTRACTION AND CONSOLIDATION. COMPLETE RESOLUTION OF THE OSSEOUS ALTERATIONS WAS ACHIEVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 12441199 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Osteolysis

  MAUDE report 12440928 ↗
• MalfunctionMar 30, 2021Corroded; Corroded

  DURING EXPLANT OF THE NAIL AFTER ACHIEVING ITS INTENDED RESULT, IT WAS NOTED THE NAIL WAS CORRODED. NO ADVERSE EVENT OR PATIENT IMPACT WAS REPORTED. IT WAS SUBSEQUENTLY REPORTED THAT AFTER THE NAIL WENT THROUGH THE STERILE CLEANING PROCESS AT THE REPORTING FACILITY, THE REPORTED CORROSION WAS NO LONGER VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593080 ↗
• InjuryMar 29, 2021Break; Corroded; Break; Corroded

  ADDITIONAL INFORMATION WAS RECEIVED VIA REVIEW OF LITERATURE THAT THE PATIENT ALSO EXPERIENCED SWELLING, OSTEOLYSIS, PERIOSTEAL REACTION, AND BONY HYPERTROPHY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Osteolysis; Pain

  MAUDE report 11586720 ↗
• InjuryMar 29, 2021Break; Corroded; Break; Corroded

  INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A SUDDEN ONSET OF PAIN AND UPON REMOVAL, THE NAIL WAS FOUND BROKEN AND THERE WERE SIGNS OF CORROSION. RADIOLOGICAL CHANGES WERE ALSO REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Osteolysis; Pain

  MAUDE report 11586717 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Osteolysis; Pain

  MAUDE report 11092364 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE OSTEOLYSIS WAS LYTIC ONLY.

  Patient problems: Osteolysis

  MAUDE report 11092351 ↗
• MalfunctionNov 20, 2020Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. PER THE REPORTER, THE NAIL WAS BROKEN. THE SURGEON BELIEVES IT MAY HAVE BEEN DUE TO FATIGUE AND SLOW BONE HEALING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10880737 ↗