MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE®; SPROTTE®_WITH LOUPE ATTACHMENT AND INTRODUCER_SPINAL ANAESTHESIA

Model Number	141151-27A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Irn# (b)(4).Original text (france): le (b)(6) 2024 matin, l'anesthésiste réalise une rachi anesthésie chez une patiente qui a déjà eu une chirurgie du rachis (sans pose de matériel).Lors de la réalisation de la rachi anesthésie sensation de tissu sous cutanée dur et rippant lors de l'avancé de l'aiguille probablement en rapport avec la fibrose post opération.Sensation de dureté importante au bout de l'aiguille de l'anesthésiste en rapport avec un contact osseux.Retrait de l'aiguille pour réorientation.Constatation qu'il manque une partie importante de l'aiguille, le médecin en déduit donc que le reste est à l'intérieur de la patiente.Annulation de l'opération et report afin de la prendre en charge et retirer sous scanner ce corps étranger.Lors du scanner diagnostique : bout de l'aiguille en contact avec le processus transverse gauche de l5 et l'autre extrémité dans le tissu adipeux à 4 cm sous la surface de la peau.Succès de l'intervention du radiologue qui a réalisé l'ablation de l'aiguille sous anesthésie locale guidée par scanner.Translation text (english): on the morning of (b)(6) 2024, the anaesthetist performed a rachi anaesthesia on a patient who had already undergone spinal surgery (without the use of equipment).When performing the rachi anesthesia, the patient experienced a sensation of hard subcutaneous tissue that rippled when the needle was advanced, probably due to postoperative fibrosis.Sensation of significant hardness at the tip of the anaesthetist's needle, related to bone contact.Needle withdrawn for reorientation.A large part of the needle is found to be missing, so the doctor deduces that the rest is inside the patient.The operation was cancelled and postponed so that the foreign body could be removed under scan.On diagnostic scan: tip of needle in contact with left transverse process of l5 and other end in adipose tissue 4 cm below skin surface.Successful intervention by the radiologist, who removed the needle under ct-guided local anaesthetic.
Additional Manufacturer Narrative
Event took place in france.Based on analysis, risk assessment, risk profile and clinical monitoring this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.This is an inital and fu1 report - combined.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoringthis file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.

• Brand Name: SPROTTE®
• Common Device Name: SPROTTE®_WITH LOUPE ATTACHMENT AND INTRODUCER_SPINAL ANAESTHESIA
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str.7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 20652216
• Report Number: 9611612-2024-00027
• Device Sequence Number: 6681424
• Product Code: BSP
• UDI-Device Identifier: 04048223107584
• UDI-Public: 04048223107584
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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 Model Number: 141151-27A
• Device Catalogue Number: 141151-27A
• Device Lot Number: 1525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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