PRECICE® Bone Transport System BT10-10D380-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517981288), received between Jun 20, 2023 and Jan 23, 2026 — 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-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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Failure to Advance

  IT WAS REPORTED THAT AFTER THE INITIAL OR DATE ON (B)(6) 2025 WHERE THE ANTEGRADE IMPLANTATION WAS PERFORMED WITH RETROGRADE TRANSPORT BY USING A CABLE WIRE. THE SLOT WAS MOVED DISTALLY USING FDM. A SURGICAL TOWEL WAS PLACED BETWEEN NAIL AND FDM. THE MANEUVER FUNCTIONED WITHOUT DIFFICULTY. THE IMPLANTATION OF THE NAIL PROCEEDED AS EXPECTED, MARKING THE MAGNET. THEN ON (B)(6) 2025 THERE WAS THE PATIENT ERC4 INTRODUCTION. WE RENEWED CONTACT ON (B)(6) 2025 WHERE THE SURGEON NOTICED THE INCOMPLETE OSTEOTOMY. ON (B)(6) 2025 WE HAD THE REVISION PROCEDURE. THIS INCLUDED THE COMPLETION OF THE OSTEOTOMY. AND FOLLOWING COMPLETION OF THE OSTEOTOMY, THE FAST DISTRACTOR MAX WAS APPLIED IN AN ATTEMPT TO MOVE THE SLOT. THE DEVICE WAS MAINTAINED AT THE MARKED POSITION FOR A MINIMUM OF 5 MINUTES UNDER XRAY CONTROL. NO MOVEMENT OF THE SLOT WAS OBSERVED. SUBSEQUENTLY, THE ERC 4 WAS APPLIED IN AN ADDITIONAL ATTEMPT TO ACTIVE THE SLOT MOVEMENT. AGAIN, NO MOVEMENT WAS DETECTED. THE CABLE WIRE WAS REMOVED. BASED ON INTRAOPERATIVE FINDINGS, NAIL EXCHANGE WAS DEEMED NOT SURGICALLY FEASIBLE. THE BONE TRANSPORT WILL NOW BE PERFORMED USING AN EXTERNAL RING FIXATOR. ADDITIONALLY, REGARDING REVISION SURGERY WE

  Patient problems: Failure of Implant

  MAUDE report 24167402 ↗
• InjuryNov 6, 2024Fracture; Fracture

  THE INFORMATION RECEIVED INDICATES THAT A REVISION PROCEDURE WAS PERFORMED FOLLOWING THE PATIENT¿S REPORT OF IMPLANT-RELATED PAIN. RADIOGRAPHIC IMAGING CONFIRMED THAT THE IMPLANT HAD FRACTURED. THE PATIENT REPORTED THAT NO TRAUMATIC EVENT PRECEDED THE FRACTURE. THE PATIENT'S MEDICAL HISTORY INCLUDES TREATMENT FOR A LEFT FEMUR FRACTURE UTILIZING AN EXTERNAL FIXATOR IN (B)(6) 2024, FOLLOWED BY MANAGEMENT OF BONE LOSS THROUGH THE TWO-STAGE MASQUELET TECHNIQUE.

  Patient problems: Implant Pain

  MAUDE report 20623364 ↗
• MalfunctionJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17164693 ↗