MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® NRFIT; SPROTTE® NRFIT_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INNTRODUCER)

Model Number	211163-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rn# (b)(4) complaint took place in uk.Note: lot number could not be transmitted to pajunk after several requests to the clinic.This means that no mfr and exp date could be transferable in the document.Based on risk assessment and clinical assessment this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4) incident occurred in uk: panjunk sprotte 25x90mm needle broke while pulling out, however entire needle could be retrieved.Confirmed by -noting bevel at distal end, comparing length of broken parts with another needle (90mm).Reporter notes - "idon't think there was not any excessive force involved.Just a routine spinal with mild difficulty due to high bmi.The needle break in such case raises concern.I don't think things could have been done differently from point of view of technique, human factors etc" bmi 40+.

• Brand Name: SPROTTE® NRFIT
• Common Device Name: SPROTTE® NRFIT_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INNTRODUCER)
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 22539491
• Report Number: 9611612-2025-00020
• Device Sequence Number: 20809411
• Product Code: BSP
• UDI-Device Identifier: 04048223116470
• UDI-Public: 04048223116470
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 211163-29A
• Device Catalogue Number: 211163-29A
• Device Lot Number: NOT SPECIFIED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown