ARROW IPN033776Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10816000012236), received between Jul 19, 2021 and Jul 22, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K142377); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

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.

• InjuryJul 22, 2021Break; Break

  AS REPORTED: PHYSICIAN USED ONCONTROL BONE MARROW SYSTEM NEEDLE (3.0MMX152MM) WITH ONCONTROL POWER DRIVER. WHILE COMING OUT FROM THE LESION, THE DISTAL LOCKING ASSEMBLY OF THE AFOREMENTIONED NEEDLE GAVE AWAY FROM THE ATTACHED POWER DRILL, RESULTING IN THE BREAKAGE OF THE CANNULA AT SUB TROCHANTERIC ENTRY POINT. THE PROXIMAL PART OF THE CANNULA IS STUCK BETWEEN THE SUBTROCHANTERIC REGION AND THE HEAD OF THE FEMUR. TROCAR AND EXTRA-OSSEOUS PART OF THE BROKEN CANNULA WERE REMOVED. THE PATIENT WAS TREATED IN MUMBAI AND IS BACK IN DELHI WITH A PART OF THE NEEDLE IN THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12209890 ↗
• MalfunctionJul 19, 2021Break; Break

  CUSTOMER REPORTED THAT THE DOCTOR, REGEN ORTHOSPORT USED ARROW ON CONTROL BONE MARROW SYSTEM NEEDLE (3.0MMX152MM) WITH ONCONTROL POWER DRIVER. PROCEDURE PLANNED: APPROACHING THE INTRAOSSEOUS LESION IN THE HEAD OF THE FEMUR UNDER ALL ASEPTIC PRECAUTIONS. WHILE COMING OUT FROM THE LESION, THE DISTAL LOCKING ASSEMBLY OF THE AFOREMENTIONED NEEDLE GAVE AWAY FROM THE ATTACHED POWER DRILL, RESULTING IN THE BREAKAGE OF THE CANNULA AT SUB TROCHANTERIC ENTRY POINT. CLINICAL CONSEQUENCES: THE PROXIMAL PART OF THE CANNULA IS STUCK BETWEEN THE SUBTROCHANTERIC REGION AND THE HEAD OF THE FEMUR. TROCAR AND EXTRA-OSSEOUS PART OF THE BROKEN CANNULA WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188441 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142377. One submission often covers many models, so check the product and lot details in each record.

• Z-0679-2017 · Nov 8, 2016 · Terminated
  ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adul
• Z-0676-2017 · Nov 8, 2016 · Terminated
  ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest o
• Z-0678-2017 · Nov 8, 2016 · Terminated
  OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult a
• Z-0675-2017 · Nov 8, 2016 · Terminated
  ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marro