SPROTTE® 021163-30ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048223052679), received between Apr 6, 2021 and Jun 14, 2021 — classified as 2 malfunctions.

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

• MalfunctionJun 14, 2021Break; Break

  IRN#: (B)(4). WHILST PERFORMING A SPINAL ANAESTHETIC PROCEDURE, THE NEEDLE FELL APART IN THE ANAESTHETISTS HANDS MEANING THAT A SECTION OF THE NEEDLE WAS LEFT BEHIND IN THE PATIENT. ALL BUT 5MM OF THE 90MM NEEDLE WAS LEFT INSIDE THE PATIENTS BACK (SPINE). FIRST ATTEMPT AT SPINAL, DEEP BONY RESISTANCE ENCOUNTERED. NEEDLE ENGAGED IN LIGAMENT AS WOULD BE EXPECTED. NEEDLE WITHDRAWN TO BE REPOSITIONED. NOTICED THAT NEEDLE APPEARED INCOMPLETE. ONLY STYLET APPEARED TO BE VISIBLE ON WITHDRAWAL, WITHOUT ACCOMPANYING NEEDLE. NEEDLE FRACTURE SEEN CLEARLY AT HUB. FRACTURED NEEDLE SEEN PROTRUDING FROM PATIENT. REQUEST MADE FOR SCRUB KIT, IN PARTICULAR ARTERY FORCEPS. NEEDLE FIRMLY GRASPED AND REMOVED, WITHOUT EXCESSIVE FORCE INTACT AND STRAIGHT. PICTURES TAKEN. RETAINED FOR EXAMINATION. ON EXAMINATION, NEEDLE APPEARS INTACT. SPROTTE TIP OF NEEDLE CLEARLY SEEN, WITH STRAIGHT SHAFT AND CLEAR SHEAR POINT AT HUB. LOW PROBABILITY OF RETAINED ITEM. PATIENT ALLOWED TO SIT UP AND REASSURED. FURTHER SPINAL ATTEMPTED AT LOWER INTERSPACE ON SECOND ATTEMPT. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NO INJURIES NOTED TO THE PATIENT OR THE HEALTH PROFESSIONAL. THE ANAESTHETIST MANAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11989381 ↗
• MalfunctionApr 6, 2021Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  IRN#: (B)(4). AFTER NORMAL SPINAL INJECTION, AT THE MOMENT OF REMOVING THE NEEDLE FROM THE PATIENT, THE NEEDLE BROKE UP (HUB BROKE OFF FROM THE ACTUAL NEEDLE) I HAD TO PULL OUT PART OF THE NEEDLE MANUALLY FROM THE PATIENT. NO INJURY SUSTAINED. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617410 ↗