PRECICE® Bone Transport System BT115-10SJ400-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517979025), received between Jun 24, 2022 and Jun 8, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2024Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE THE HOSPITAL DID NOT HAVE THE RIGHT S-GUIDE FOR THE NAIL. THE NAIL WAS CLEANED AND SAVED FOR IMPLANT A FEW DAYS LATER. BEFORE IMPLANTING THE NAIL AGAIN, IT WAS TESTED WITH THE FAST DISTRACTOR AND IT WOULD NOT DISTRACT. A NEW NAIL WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Failure of Implant

  MAUDE report 19493912 ↗
• MalfunctionJun 24, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED THAT X-RAY IMAGES SHOWED THE NAIL HAD BROKEN IN-SITU. THE PATIENT WAS FULL WEIGHT BEARING ON THE NAIL AS A BUILDER POST CONSOLIDATION. THE NAIL HAS BEEN EXPLANTED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14803165 ↗