PRECICE® Bone Transport System BT10-90B340-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517979995), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Disconnection” (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-1324-2021 · 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-1323-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2021Disconnection; Disconnection

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE PATIENT SUFFERING FROM A PERI-PROSTHETIC FRACTURE AROUND THE PROXIMAL NAIL SCREWS WHICH RESULTED IN A LOSS OF ALIGNMENT. ADDITIONALLY, DURING REMOVAL OF THE NAIL, THE NAIL DISASSOCIATED. IT WAS REPORTED THAT INSTEAD OF A RETENTION PLUG, THE SURGEON USED A UNILATERAL EXTERNAL FIXATOR TO HOLD ALL SEGMENTS DURING NAIL REMOVAL, WITH THE PROXIMAL APEX PIN INSERTED IN CLOSE PROXIMITY TO THE NAIL.

  Patient problems: Bone Fracture(s)

  MAUDE report 11592875 ↗