MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® NRFIT® KIT

Catalog Number	021163-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is considered as closed.If further information becomes available an update will be sent to the agency.
Event or Problem Description
(b)(4).Incident occurred in uk.Attempted spinal anaesthesia for major robotic urology surgery.Upon removal of the needle and the introducer together to attempt a final time with a longer 25g needle, i noticed that the part of the spinal needle was retained.The needle broke at the level of the introducer with the tip retained in the subcutaneous tissue.No resistance or difficulty in removing or inserting the needle.I just hit the bone a few times during the attempts.Needle visualised with us.Explained to the patient that we would need to surgically remove the needle.She understood the situation and agreed to proceed.Decided to put her under general anaesthesia to perform xray and proceed with the removal.She agreed to continue with planned surgery if removal uncomplicated.Total lidocaine 1% 20 mls.Spine surgical team arrived.Needle was identified with fluoroscopy and removed.Patient was proned for the procedure and the surgical would was of about 1 inch in length.Uneventful procedure with no immediate complication.The needle was found at the level of l2 close to the spinous process, far from the spinal canal.After the needle was removed we proceed with the planned surgery.No follow up or special requests by the spine surgeons, reabsorbable sutures in place.

• Brand Name: SPROTTE® NRFIT® KIT
• Common Device Name: SPROTTE® NRFIT® KIT
• 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: 23725456
• Report Number: 9611612-2025-00050
• Device Sequence Number: 13434757
• Product Code: CAZ
• UDI-Device Identifier: 04048223127841
• UDI-Public: 04048223127841
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown