PRECICE® STRYDE System PS10.0-65D250Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887517951175), received between Feb 23, 2021 and Aug 5, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Corroded” (8 reports).

1 FDA recall record name this device's identifier, 1 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 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 AILED 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 MID-THIGH PAIN, AND RADIOGRAPHIC OBSERVATIONS IDENTIFIED CORTICAL THICKENING AT THE EXTENDABLE JUNCTION OF THE NAIL.

  Patient problems: Implant Pain

  MAUDE report 19912219 ↗
• MalfunctionJan 27, 2022Corroded; Detachment of Device or Device Component; Naturally Worn; Corroded; Detachment of Device or Device Component; Naturally Worn

  INFORMATION WAS RECEIVED THAT UPON EXPLANT OF THE NAIL AFTER IT HAD ACHIEVED INTENDED THERAPEUTIC LENGTHENING, IT WAS NOTED THE NAIL EXHIBITED CREVICE CORROSION AND WEAR BETWEEN THE NAIL AND FIXATION SCREWS. ADDITIONALLY, IT WAS FOUND THAT THE CROWN OF THE NAIL HAD BECOME DISPLACED AND APPEARED TO HAVE COLD-WELDED TO THE MALE COMPONENT INSTEAD OF STAYING WITHIN THE FEMALE COMPONENT. NO PATIENT HARM OR ADVERSE IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367931 ↗
• MalfunctionJan 27, 2022Corroded; Detachment of Device or Device Component; Naturally Worn; Corroded; Detachment of Device or Device Component; Naturally Worn

  INFORMATION WAS RECEIVED THAT UPON EXPLANT OF THE NAIL AFTER IT HAD ACHIEVED INTENDED THERAPEUTIC LENGTHENING, IT WAS NOTED THE NAIL EXHIBITED CREVICE CORROSION AND WEAR BETWEEN THE NAIL AND FIXATION SCREWS. ADDITIONALLY, IT WAS FOUND THAT THE CROWN OF THE NAIL HAD BECOME DISPLACED AND APPEARED TO HAVE COLD-WELDED TO THE MALE COMPONENT INSTEAD OF STAYING WITHIN THE FEMALE COMPONENT. NO PATIENT HARM OR ADVERSE IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367897 ↗
• MalfunctionNov 22, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT UPON EXPLANT THE NAIL WAS NOTED TO HAVE CREVICE CORROSION AT THE JUNCTION SITE OF THE MALE AND FEMALE COMPONENTS BETWEEN THE SCREWS AND SCREW HOLES OF THE NAIL. CORROSION WAS ALSO NOTED ON THE MALE COMPONENT AND DISTAL SCREW HOLES. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852264 ↗
• MalfunctionSep 15, 2021Corroded; Corroded

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478165 ↗
• MalfunctionAug 23, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT UPON EXPLANT CORROSION WAS SEEN ON THE NAIL. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356736 ↗
• MalfunctionAug 3, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT UPON EXPLANT THE NAIL WAS NOTICED TO HAVE DISCOLORATION AROUND THE TELESCOPING AREA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267879 ↗
• MalfunctionJun 2, 2021Material Erosion; Material Erosion

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 11922080 ↗
• MalfunctionMay 6, 2021Corroded; Corroded

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787559 ↗
• InjuryFeb 23, 2021Degraded; Degraded

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 11369910 ↗