SPROTTE NRFitRecalls & reported problems across all models

We found 7 models of SPROTTE NRFit by Pajunk GmbH Medizintechnologie in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2018 and Feb 27, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SPROTTE NRFit problems

SPROTTE NRFit models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SPROTTE® NRFit 121163-30A

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  9 reports
• SPROTTE® NRFit 021163-29A

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  5 reports
• SPROTTE® NRFit 001163-30A

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  4 reports
• SPROTTE® NRFit 021163-27A

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  1 report
• SPROTTE® NRFit 021163-29A

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  1 report
• SPROTTE® NRFit 051163-29A

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  1 report
• SPROTTE® NRFit 211163-29A

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  1 report

Recent SPROTTE NRFit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Break

  IRN#: 033-26_1078. INCIDENT OCCURRED IN UK. THE SPINAL NEEDLE BROKE WHILST IN THE PATIENT REQUIRING SURGICAL REMOVAL BY NEUROSURGICAL TEAM UNDER GENERAL ANAESTHETIC.

  Patient problems: Foreign Body In Patient

  MAUDE report 24468214 ↗
• InjuryDec 5, 2025Break; Break

  (B)(4). INCIDENT OCCURRED IN UK. ATTEMPTED SPINAL ANAESTHESIA FOR MAJOR ROBOTIC UROLOGY SURGERY. UPON REMOVAL OF THE NEEDLE AND THE INTRODUCER TOGETHER TO ATTEMPT A FINAL TIME WITH A LONGER 25G NEEDLE, I NOTICED THAT THE PART OF THE SPINAL NEEDLE WAS RETAINED. THE NEEDLE BROKE AT THE LEVEL OF THE INTRODUCER WITH THE TIP RETAINED IN THE SUBCUTANEOUS TISSUE. NO RESISTANCE OR DIFFICULTY IN REMOVING OR INSERTING THE NEEDLE. I JUST HIT THE BONE A FEW TIMES DURING THE ATTEMPTS. NEEDLE VISUALISED WITH US. EXPLAINED TO THE PATIENT THAT WE WOULD NEED TO SURGICALLY REMOVE THE NEEDLE. SHE UNDERSTOOD THE SITUATION AND AGREED TO PROCEED. DECIDED TO PUT HER UNDER GENERAL ANAESTHESIA TO PERFORM XRAY AND PROCEED WITH THE REMOVAL. SHE AGREED TO CONTINUE WITH PLANNED SURGERY IF REMOVAL UNCOMPLICATED. TOTAL LIDOCAINE 1% 20 MLS. SPINE SURGICAL TEAM ARRIVED. NEEDLE WAS IDENTIFIED WITH FLUOROSCOPY AND REMOVED. PATIENT WAS PRONED FOR THE PROCEDURE AND THE SURGICAL WOULD WAS OF ABOUT 1 INCH IN LENGTH. UNEVENTFUL PROCEDURE WITH NO IMMEDIATE COMPLICATION. THE NEEDLE WAS FOUND AT THE LEVEL OF L2 CLOSE TO THE SPINOUS PROCESS, FAR FROM THE SPINAL CANAL. AFTER THE NEEDLE WAS REMOVED WE PROCEED WITH THE PLANNED

  Patient problems: Foreign Body In Patient

  MAUDE report 23725456 ↗
• MalfunctionJan 27, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IRN# (B)(4). NRFIT PACKET CONTAINED A NON NRFIT SPINAL NEEDLE. ANAESTHETIST WAS UNABLE TO ADMINISTER BLOCK WITHOUT REMOVING AND CHANGING THE SPINAL NEEDLE. NARRATIVE FROM THE CER: THE HOSPITAL HAVE CONVERTED TO NRFIT. THEY USE NRFIT SPROTTE. THEY OPENED A BOX OF NRFIT SPROTTE NEEDLESIN THEATRES, OPENED THE PACKET, TOOK THE NEEDLE OUT, INSERTED IT INTO THE PATIENT, AND FOUND THE NRFIT SYRINGE WOULDNT CONNECT. ON CLOSER INSPECTION, THEY FOUND THIS NEEDLE TO BE A LUER SPROTTE. STAFF THEN OPENED ANOTHER BOX AND FOUND 1 X MORE UNIT OF A LUER SPROTTE, IN A NRFIT SPROTTE BOX. HENCE THE 2 X LOT NUMBERS. THEATRE STAFF ON SITE DISPOSED OF THE NEEDLES INTO THE SHARPS BIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11234658 ↗
• MalfunctionDec 8, 2020Nonstandard Device; Material Deformation; No Flow; Nonstandard Device; Material Deformation; No Flow

  (B)(4). CATEGORY ONE LSCS, SPINAL ANAESTHETIC. CLINICALLY STRAIGHTFORWARD SPINAL ANAESTHETIC, NO DIFFICULTY OBTAINING CLINICAL END POINT OF SPINAL NEEDLE INSERTION. ON REMOVING CENTRE PORTION OF SPINAL NEEDLE IT FELT VERY GRATEY, IT WAS NOT SMOOTH AS YOU WOULD EXPECT. NO CSF, SEEN FROM NEEDLE, WHICH WAS SURPRISING AS CLINICALLY I FELT I WAS IN THE CORRECT PLACE. SWITCHED TO NEW NEEDLE, WHICH I INSERTED THROUGH SAME INTRODUCER WITH NO OTHER ADJUSTMENTS. CENTRE PART REMOVED SMOOTHLY AS YOU WOULD EXPECT AND FREE FLOWING CSF WAS SEEN. SPINAL ANAESTHETIC SUCCESSFULLY. ON EXAMINING THE FIRST NEEDLE AFTER THE EVENT IT APPEARED BENT. THE EXACT SAME THING HAPPENED TO ME ON (B)(6) 2020, WITH A GRATEY SENSATION ON REMOVING CENTRE PORTION OF NEEDLE, NO CSF DESPITE GOOD CLINICAL END POINT, NEEDLE APPEARED BENT ON REMOVAL DESPITE NON DIFFICULT INSERTION. THE LOT NUMBERS (1324) ETC ARE IDENTICAL ON BOTH NEEDLES BUT THE HUB ON THE GRATEY ONE WAS A PALER PURPLE. ON EXAMINING THE SELECTION OF NEEDLES THERE WAS A MIXTURE OF ONES WITH A PALE AND DARKER PURPLE HUB ALL WITH IDENTICAL LOT NUMBERS. ON OPENING ANOTHER PALE PURPLE HUBBED NEEDLE, AGAIN THE CENTRE BIT WAS GRATEY TO REMOVE, NOT SMOOTH AS IT SH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964104 ↗
• MalfunctionDec 8, 2020Nonstandard Device; Material Deformation; No Flow; Nonstandard Device; Material Deformation; No Flow

  (B)(4). CATEGORY ONE LSCS, SPINAL ANAESTHETIC. CLINICALLY STRAIGHTFORWARD SPINAL ANAESTHETIC, NO DIFFICULTY OBTAINING CLINICAL END POINT OF SPINAL NEEDLE INSERTION. ON REMOVING CENTRE PORTION OF SPINAL NEEDLE IT FELT VERY GRATEY, IT WAS NOT SMOOTH AS YOU WOULD EXPECT. NO CSF, SEEN FROM NEEDLE, WHICH WAS SURPRISING AS CLINICALLY I FELT I WAS IN THE CORRECT PLACE. SWITCHED TO NEW NEEDLE, WHICH I INSERTED THROUGH SAME INTRODUCER WITH NO OTHER ADJUSTMENTS., CENTRE PART REMOVED SMOOTHLY AS YOU WOULD EXPECT AND FREE FLOWING CSF WAS SEEN. SPINAL ANAESTHETIC SUCCESSFULLY. ON EXAMINING THE FIRST NEEDLE AFTER THE EVENT IT APPEARED BENT. THE EXACT SAME THING HAPPENED TO ME ON (B)(6) 2020, WITH A GRATEY SENSATION ON REMOVING CENTRE PORTION OF NEEDLE, NO CSF DESPITE GOOD CLINICAL END POINT, NEEDLE APPEARED BENT ON REMOVAL DESPITE NON DIFFICULT INSERTION. THE LOT NUMBERS (1324) ETC ARE IDENTICAL ON BOTH NEEDLES BUT THE HUB ON THE GRATEY ONE WAS A PALER PURPLE. ON EXAMINING THE SELECTION OF NEEDLES THERE WAS A MIXTURE OF ONES WITH A PALE AND DARKER PURPLE HUB ALL WITH IDENTICAL LOT NUMBERS. ON OPENING ANOTHER PALE PURPLE HUBBED NEEDLE, AGAIN THE CENTRE BIT WAS GRATEY TO REMOVE, NOT SMOOTH AS IT S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964103 ↗
• MalfunctionDec 8, 2020Nonstandard Device; Material Deformation; No Flow; Nonstandard Device; Material Deformation; No Flow

  (B)(4). CATEGORY ONE LSCS, SPINAL ANAESTHETIC. CLINICALLY STRAIGHTFORWARD SPINAL ANAESTHETIC, NO DIFFICULTY OBTAINING CLINICAL END POINT OF SPINAL NEEDLE INSERTION. ON REMOVING CENTRE PORTION OF SPINAL NEEDLE IT FELT VERY GRATEY, IT WAS NOT SMOOTH AS YOU WOULD EXPECT. NO CSF, SEEN FROM NEEDLE, WHICH WAS SUPRISING AS CLINICALLY I FELT I WAS IN THE CORRECT PLACE. SWITCHED TO NEW NEEDLE, WHICH I INSERTED THROUGH SAME INTRODUCER WITH NO OTHER ADJUSTMENTS., CENTRE PART REMOVED SMOOTHLY AS YOU WOULD EXPECT AND FREE FLOWING CSF WAS SEEN. SPINAL ANAESTHETIC SUCCESSFULLY. ON EXAMINING THE FIRST NEEDLE AFTER THE EVENT IT APPEARED BENT. THE EXACT SAME THING HAPPENED TO ME ON (B)(6) 2020, WITH A GRATEY SENSATION ON REMOVING CENTRE PORTION OF NEEDLE, NO CSF DESPITE GOOD CLINICAL END POINT, NEEDLE APPEARED BENT ON REMOVAL DESPITE NON DIFFICULT INSERETION. THE LOT NUMBERS (1324) ETC ARE IDENTICAL ON BOTH NEEDLES BUT THE HUB ON THE GRATEY ONE WAS A PALER PURPLE. ON EXAMINING THE SELECTION OF NEEDLES THERE WAS A MIXTURE OF ONES WITH A PALE AND DARKER PURPLE HUB ALL WITH IDENTICAL LOT NUMBERS. ON OPENING ANOTHER PALE PURPLE HUBBED NEEDLE, AGAIN THE CENTRE BIT WAS GRATEY TO REMOVE, NOT SMOOTH AS IT S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964100 ↗
• MalfunctionAug 5, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IRN#:(B)(4). WHILST PERFORMING A SPINAL ANAESTHETIC THE PLASTIC HUB OF THE NEEDLE BROKE AWAY FROM THE METAL NEEDLE, LEAVING THE METAL NEEDLE STICKING OUT OF THE PATIENTS BACK. NO EXCESSIVE FORCE WAS USED. THIS IS THE ONLY REPORT OF SUCH AN INCIDENT IN OUR ANAESTHETIC DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10369803 ↗
• MalfunctionOct 31, 2019Component Misassembled; Component Misassembled

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: "PATIENT REQUIRING SPINAL ANAESTHETIC. DIFFICULT TO DO, MULTIPLE NEEDLES USED. ONE NEEDLE MANAGED TO GET INTO CSF UNFORTUNATELY HAD A LEUR LOCK CONNECTION THEREFORE IT WAS NOT POSSIBLE TO INFILTRATE ANY MEDICATION. SUBSEQUENT NEEDLE HAD TO BE PASSED AND PATIENT SUFFERED AN UNNECESSARY DURAL PUNCTURE. ON INVESTIGATION AFTERWARDS IT APPEARED THE LEUR LOCK NEEDLE HAD BEEN IN AN NRFIT PACKAGE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260280 ↗
• MalfunctionOct 31, 2019Crack; Component Misassembled; Crack; Component Misassembled

  (B)(4). INITIAL REPORTER´S NARRATIVE: "UPON INJECTION OF THE SPINAL ANAESTHETIC IT WAS OBSERVED THAT THE HUB OF THE NEEDLE WAS CRACKED & SUBSEQUENTLY THE ANAESTHETIC WAS LEAKING & RUNNING DOWN THE HUB & NEEDLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9259874 ↗
• MalfunctionOct 24, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: CER: PERFORMED A SPINAL INJECTION AND ON THE REMOVAL OF THE NEEDLE FROM THE PATIENT THE NEEDLE HUB CAME AWAY FROM THE NEEDLE ITS SELF. THIS WAS A STRAIGHTFORWARD PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9231205 ↗
• MalfunctionOct 2, 2019Crack; Crack

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: AN INJECTION LEAKAGE OCCURED AROUND THE HUB OF THE 24G X 90MM SPROTTE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9143778 ↗
• MalfunctionOct 2, 2019Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: PERFORMED SPINAL AS USUAL ALTHOUGH LIGAMNET WAS TOUGH, THE SPINAL WORKED FINE. ON REMOVAL OF THE SPINAL NEEDLE THE HUB WAS DETACHED FROM THE METAL PART. SURGICAL NEEDLE HOLDERS WERE REQUIRED TO REMOVE THE METAL PART OF THE NEEDLE FROM THE PATIENTS BACK.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9143775 ↗
• MalfunctionOct 2, 2019Crack; Crack

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: LEAKAGE AT THE HUB NEEDLE CONNECTION UPON PRIMING OF NEEDLE. ALL OUTSTANDING NEEDLES OF AFFECTED LOT NUMBER HAVE BEEN COLLECTED FROM ALL CLINICAL AREAS AND STORES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9143772 ↗
• MalfunctionJun 19, 2019Break; Break

  (B)(4). NEEDLE BREAKAGE WHILE A SPINAL WAS IN PROCESS. IT BENT WHERE THE NEEDLE LEFT THE INTRODOCER. AFTER STRAIGHTENED OUT THE NEEDLE BROKE. BROKEN END REMOVED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8710526 ↗
• MalfunctionApr 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IRN# 620_109-19. INITIAL REPORTER´S NARRATIVE: PATIENT ON ELECTIVE CAESAREAN SECTION LIST. STRAIGHTFORWARD SPINAL USING THE NR FIT PAJUNK SPROTTE 25G 90MM NEEDLE VIA THE SUPPLIED 30MM INTRODUCER NEEDLE. INJECTED SPINAL DRUGS UNEVENTFULLY. ATTEMPTED TO REMOVE THE INTRODUCER AND SPINAL NEEDLE AS A SINGLE UNIT WHEREUPON THE HUB OF THE SPINAL NEEDLE DETACHED FROM THE NEEDLE LEAVING THE NEEDLE PROTRUDING FROM THE PATIENT'S BACK. THE NEEDLE WAS SUBSEQUENTLY REMOVED MANUALLY AND WAS INTACT.

  Patient problems: Inadequate Pain Relief; No Known Impact Or Consequence To Patient

  MAUDE report 8502928 ↗

Other Pajunk GmbH Medizintechnologie products

• SPROTTE32 models · 59 reports
• SPROTTE 2.G5 models · 21 reports