ONCONTROL IPN919019Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156108502), received between Aug 25, 2023 and Apr 16, 2025 — classified as 1 injury, 1 malfunction.

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

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 16, 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.

• MalfunctionApr 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "DURING A BONE MARROW BIOPSY ON A PATIENT WITH A 4" NEEDLE. HE HAD EXTREMELY HARD BONES. WE WERE ABLE TO GET INTO THE ASPIRATE MANUALLY AND GOT LIQUID ASPIRATE. WHEN TRYING TO USE THE DRIVER TO OBTAIN A CORE, THE NEEDLE BENT AT THE ORANGE PART. WHEN TRYING TO RETRACT THE DRIVER, THE ORANGE PIECE SNAPPED OFF THE NEEDLE. AFTER USING A KELLY CLAMP, WE WERE ABLE TO REMOVE THE NEEDLE. HOWEVER, IT APPEARS THAT THE TIP OF THE BORE NEEDLE WAS NOT FULLY INTACT. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846976 ↗
• InjuryAug 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: DR. PERFORMING BMB AND BIOPSY NEEDLE BROKE OFF IN PATIENT WHEN IN USE. NEEDLE STILL STUCK IN ILIAC CREST. ADDITIONAL INFORMATION: PHYSICIAN WAS USING A BMB KIT ON A HARD, SCLEROTIC BONE LESION BIOPSY. PHYSICIAN DID NOT EXPECT THE PATIENT TO HAVE HARD BONES. HE WAS NOT ABLE TO ADVANCE WITH NEEDLE , SO HE TRIED TO REDIRECTED CANNULA WITH DRIVER , EXCESSIVE FORCE WAS USED. HE BELIEVES THE NEEDLE WAS STUCK IN THE BONE AND SNAPPED THE CANNULA WHEN HE WAS TRYING TO REDIRECT. I MENTIONED TO PHYSICIAN THAT THE BML TRAY WOULD HAVE PROBABLY BEEN A BETTER CANNULA TO CUT THROUGH THE HARD BONE, HE AGREED. 2CM OF CANNULA TIP WAS IMBEDDED IN PATIENTS' BONE AND WERE UNABLE TO RETRIEVE. THEY DECIDED TO LEAVE THE PIECE IN THE BODY SINCE IT WOULD NOT BE HARMFUL TO PATIENT. PATIENT IS FINE AND PHYSICIAN DOES NOT FEEL IT WAS DEVICE FAULT. WENT OVER TRAYS WITH PHYSICIAN TO SHOW THE DIFFERENCE OF THE CANNULA TIPS IN THE BMB KITS AND BML. FOR HARD BONE, BML IS THE APPROPRIATE KIT TO USE TO HELP CUT BETTER. PHYSICIAN WILL USE BML ON THE HARD BONE CASES.

  Patient problems: Foreign Body In Patient

  MAUDE report 17622042 ↗