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

Model Number	021163-29A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Irn# (b)(4).Complaint took place in united kingdom.In the process of administering single shot spinal anaesthesia on two occassions (same patient) the dr bent the sprotte (photo attached).When described he was reasonably sure he had not hit bone, though i am not so sure.He successfully used another needle to complete and then for the following case without incident.
Additional Manufacturer Narrative
Irn# (b)(4).Complaint took place in united kingdom.This is a complete report with all the information and test results that were available at the given time.The failure sample was not sent to pajunk for testing - a picture was send.Based on clinical assessment and risk assessment this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.

• Brand Name: SPROTTE® NRFIT® (WITH INTRODUCER)
• Common Device Name: SPROTTE® NRFIT®_NEEDLE CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• 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: 20785478
• Report Number: 9611612-2024-00029
• Device Sequence Number: 9053155
• Product Code: BSP
• UDI-Device Identifier: 04048223114803
• UDI-Public: 04048223114803
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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 Expiration Date: 05/03/2026
• Device Model Number: 021163-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown