Jamshidi DJ3513XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403087110), received between Dec 21, 2021 and Jun 19, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER WHILE USING THE PEDIATRIC JAMSHIDI (DJ3513X) NEEDLE ON A PATIENT, THE DISTAL PORTION BROKE OFF AND BECAME LODGED IN THE RIGHT ANTERIOR ILIAC SPINE. VERBATIM: WHILE USING THE PEDIATRIC JAMSHIDI (DJ3513X) NEEDLE ON A PATIENT, THE DISTAL PORTION BROKE OFF AND BECAME LODGED IN THE RIGHT ANTERIOR ILIAC SPINE. DESCRIBE PATIENT / (HCP) / USER IMPACT: ORTHOPEDIC SURGERY IS GOING TO SEE THE PATIENT TOMORROW AFTERNOON TO EVALUATE. CUSTOMER RESPONSE RECEIVED ON 18-JUN-2024: 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? I DON'T HAVE THIS. 2. WAS THE JAMSHIDI NEEDLE BROKEN OFF IN RIGHT ANTERIOR ILIAC SPINE? YES, RIGHT ANTERIOR ILIAC SPINE. 3. HOW WAS ITEM PIECE RETRIEVED FROM PATIENT/PROCEDURE? TIP OF DEVICE REMAINS LODGED IN THE PATIENT. 4. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? ADDITIONAL RADIOGRAPHS WERE OBTAINED TO LOCATE TIP OF DEVICE AND PATIENT FOLLOWED UP WITH ORTHOPEDIC SURGERY FOR EVALUATION. 5. WHAT WAS THE IMPACT TO THE PATIENT? ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. PATIENT NOW HAS FOREIG

  Patient problems: Foreign Body In Patient

  MAUDE report 19566941 ↗
• InjuryJul 14, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE BROKE OFF AND WAS LEFT IN THE PATIENT'S LEFT ILIUM. VERBATIM: THE NEEDLE BROKE OFF IN THE PATIENT¿S LEFT ILIUM. THE TIP WHICH WAS LEFT IN SITU MEASURED APPROXIMATELY 7MM X 2MM ON XRAY. THE DECISION WAS MADE TO LEAVE IT IN PLACE SINCE ATTEMPTING TO REMOVE IT FROM THE HIP WOULD BE MORE INVASIVE. THIS IS THE SECOND ONE I AM AWARE OF NOW (THE OTHER WAS (B)(6) OF 2021). PATIENT HAS REMAINDER OF NEEDLE IN THEIR BONE AND SURGICAL REMOVAL WOULD CAUSE MORE HARM THAN LEAVING THERE. CONFIDENCE IN PROVIDER, PRODUCT AND HEALTH SYSTEM HAS DECREASED FOR THIS PATIENT AND THEIR GUARDIANS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15017626 ↗
• InjuryDec 21, 2021Break; Break

  IT WAS REPORTED THAT NEEDLE TIP BROKE OFF IN PATIENT DURING PROCEDURE. ¿ESSENTIALLY DURING THE PROCEDURE WHERE THE APP WAS ATTEMPTING TO CORE THE BIOPSY SPECIMEN, THE ENTIRE TIP (A LITTLE OVER 1 CM OF LENGTH) BROKE OFF THE NEEDLE IN THE PATIENT¿S BONE. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE METAL TIP BACK OUT, BUT IT WAS ULTIMATELY DECIDED TO LEAVE IN SITU. THIS IS THE FIRST TIME I HAVE HEARD OF THIS OCCURRING, I WAS QUITE SURPRISED TO GET THAT CALL. THE ITM NUMBER FOR THE NEEDLE IS ITM-1120387 NEEDLE JAMSHIDI 13G 3.5¿. THIS INSTANCE HAS A LOT NUMBER OF 0001418607. THE REMAINDER OF THE PRODUCT IS IN THE BAG ALONG WITH THE PACKAGING, IT DOES HAVE SOME BLOOD ON IT AS IT WAS USED ON THE PATIENT SO IT IS IN A BIOHAZARD SPECIMEN BAG. TIP LEFT IN PATIENT AT THIS TIME. UNSURE IF IT WILL END UP BEING PROBLEMATIC AND CAUSING HARM. CAUSING ADDITIONAL PROCEDURE LENGTH, INCREASED FOLLOW UP CARE AND POTENTIAL FUTURE SURGERY TO REMOVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13052831 ↗