PRECICE® Bone Transport System BT115-10SJ360-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517979063), received between Nov 8, 2019 and Jul 7, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 ↗

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-1324-2021 · 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.

• MalfunctionJul 7, 2021Fracture; Fracture

  INFORMATION WAS RECEIVED THAT DURING EXPLANTATION, A BROKEN NAIL AND FIXATION SCREW WERE OBSERVED. NO PATIENT IMPACT WAS REPORTED. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131903 ↗
• MalfunctionJul 22, 2020Separation Failure; Separation Failure

  INFORMATION WAS RECEIVED DURING A NAIL REMOVAL ON (B)(6) 2020, THE DISTAL END OF THE NAIL PULLED APART DUE TO THE RETENTION PLUG NOT BEING UTILIZED. AS PER THE REPORTER, ALL THE PIECES OF THE NAIL WERE RETRIEVED.

  Patient problems: Failure of Implant

  MAUDE report 10311979 ↗
• InjuryNov 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT A REMOVAL SURGERY WAS COMPLETED IN (B)(6) OF 2019. AS PER REPORTER, THE PATIENT DEVELOPED AN INFECTION (NON-IMPLANT RELATED) AND THE SURGEON NEEDED TO REMOVE THE NAIL AND PUT ON EXTERNAL FIXATION. A FEW DAYS LATER, FOR FOLLOW UP OF THE EXTERNAL FIXATION PINS, IT WAS OBSERVED ON X-RAYS THAT THE BONE TRANSPORT NAIL HAD DISASSOCIATED DURING THE REMOVAL PROCESS AND SOME OF THE COMPONENTS WERE LEFT BEHIND IN THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 9298653 ↗