PRECICE® STRYDE System PS13.0-80B280Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517950918), received between Mar 3, 2020 and Aug 31, 2023 — classified as 4 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 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA THE PATIENT THAT THE THEY HAVE BEEN EXPERIENCING SEVERE PAIN AND ARE RESTRICTED DUE TO THE SEVERITY OF THE PAIN. THE PATIENT IS BARELY ABLE TO PICK UP AN OBJECT FROM FLOOR LEVEL OR ENDURE SITTING FOR LONG PERIODS OF TIME AND WALKING HURTS AS THE PAIN IS CONSTANT. ADDITIONALLY, THEY REPORTED THAT THEY HAVE OCCASIONALLY TAKEN PAIN MEDICATION WHICH EASED THE SHARPNESS BUT NOT ENOUGH NOR LONG ENOUGH. THE PATIENT HAS TO PUSH THEMSELVES UP USING THEIR ARMS WHEN STANDING UP AND HAS TROUBLE DRIVING. AT TIMES THEIR KNEE WILL TRY TO BUCKLE AND THEY HAVE A LOT OF SWELLING IN THE LOWER LEG. ONCE THE BONE HEALED THE PAIN REPORTEDLY GOT WORSE. THE NAIL REMAINS IMPLANTED AT THIS TIME. A REVISION IS PLANNED FOR AN UNKNOWN DATE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Limb Pain

  MAUDE report 17662446 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA THE PATIENT THAT THE THEY HAVE BEEN EXPERIENCING SEVERE PAIN AND ARE RESTRICTED DUE TO THE SEVERITY OF THE PAIN. THE PATIENT IS BARELY ABLE TO PICK UP AN OBJECT FROM FLOOR LEVEL OR ENDURE SITTING FOR LONG PERIODS OF TIME AND WALKING HURTS AS THE PAIN IS CONSTANT. ADDITIONALLY, THEY REPORTED THAT THEY HAVE OCCASIONALLY TAKEN PAIN MEDICATION WHICH EASED THE SHARPNESS BUT NOT ENOUGH NOR LONG ENOUGH. THE PATIENT HAS TO PUSH THEMSELVES UP USING THEIR ARMS WHEN STANDING UP AND HAS TROUBLE DRIVING. AT TIMES THEIR KNEE WILL TRY TO BUCKLE AND THEY HAVE A LOT OF SWELLING IN THE LOWER LEG. ONCE THE BONE HEALED THE PAIN REPORTEDLY GOT WORSE. THE NAIL REMAINS IMPLANTED AT THIS TIME. A REVISION IS PLANNED FOR AN UNKNOWN DATE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Limb Pain

  MAUDE report 17662425 ↗
• InjuryNov 16, 2020Mechanical Problem; Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10849229 ↗
• InjuryMar 3, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2020. AS PER REPORTER, X-RAY IMAGES REVEALED THAT THE NAIL ON THE LEFT SIDE WAS NOT LENGTHENING.

  Patient problems: Failure of Implant

  MAUDE report 9783286 ↗