MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® STANDARD

Catalog Number	121151-27A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Incident occurred in france.During spinal anesthesia for a cesarean section, the needle broke just behind the base upon contact with a vertebra.The anesthesiologist reported no prior deformation or twisting of the needle.The break occurred immediately.The needle was removed and replaced.No clinical consequences for the patient.
Additional Manufacturer Narrative
This case is considered as closed.If further information becomes available an update will be send to the agency.

• Brand Name: SPROTTE® STANDARD
• Common Device Name: SPROTTE® STANDARD
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 24766260
• Report Number: 9611612-2026-00006
• Device Sequence Number: 9299431
• Product Code: BSP
• UDI-Device Identifier: 04048223130179
• UDI-Public: 04048223130179
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K241953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 121151-27A
• Device Lot Number: 1545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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