MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® 2.G; SPROTTE® 2.G_NEEDLE, CONDUCTION, ANESTHETIC (W/W0 INTRODUCER)

Model Number	041251-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Irn#(b)(4).Complaint took place in italy.This incident was classified as co-reported for usa on 07-02-2025 after reassessment.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 italy: while removing the needle to change position, it broke and the stump remained inside the patient, impossible to remove with bare hands (about 4.5cm).Therefore, the patient required a diagnostic-therapeutic pathway, which ended with the removal of the stump by the neurosurgery colleagues.No neurological damage was reported in the patient throughout the periprocedural pathway.
Additional Manufacturer Narrative
(b)(4).Complaint took place in italy.G1 correction: insert email adress.This incident was classified as co-reported for usa on 07-02-2025 after reassessment.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 italy: while removing the needle to change position, it broke and the stump remained inside the patient, impossible to remove with bare hands (about 4.5cm).Therefore, the patient required a diagnostic-therapeutic pathway, which ended with the removal of the stump by the neurosurgery colleagues.No neurological damage was reported in the patient throughout the periprocedural pathway.

• Brand Name: SPROTTE® 2.G
• Common Device Name: SPROTTE® 2.G_NEEDLE, CONDUCTION, ANESTHETIC (W/W0 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: 22381699
• Report Number: 9611612-2025-00022
• Device Sequence Number: 9582822
• Product Code: BSP
• UDI-Device Identifier: 04048223104316
• UDI-Public: 04048223104316
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 041251-29A
• Device Catalogue Number: 041251-29A
• Device Lot Number: 1541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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