MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® LUMBAR; SPROTTE® LUMBAR 21G X 90MM

Catalog Number	321151-31A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Irn#(b)(4).Incident occured in switzerland.Sprotte lumbar is broken off.
Additional Manufacturer Narrative
Irn#(b)(4).Incident occurred in switzerland.The final results will be sent to agency after investigation of affected device.
Additional Manufacturer Narrative
Irn # (b)(4) incident occurred in switzerland.After the initial reporter submitted the update from the swiss medic report, the initial reporter changed in the report and the codes under h6.Furthermore, the date of awareness was added to the report.This case is considered as closed.If further information becomes available an update will be sent to the agency.
Event or Problem Description
Irn# (b)(4) incident occured in switzerland.On (b)(6) 2025: sprotte lumbar is broken off on (b)(6) 2025: update of event problem: performing a lumbar puncture on a patient with dementia (a.E.Lewy body).Indication: determination of dementia markers.Patient in left lateral position, after marking the puncture site at the level of the upper edge of the os ilii, disinfection and sterile draping.The assistant doctor then inserts the spacer needle between the spinous processes.After a slight readjustment due to resistance, the needle can be inserted as far as it will go.Three unsuccessful attempts are made to puncture with the puncture needle through the spacer, with the usual readjustment after each attempt (the spacer remains in situ throughout).Then there is a change of hands; the puncture needle is completely withdrawn for this purpose, while the spacer remains in situ.When reinserting the needle through the spacer, there is resistance; the needle seems to rub slightly against the spacer.With a little more pressure from the puncture hand, holding the back of the needle, the resistance can be overcome and 2-3 further unsuccessful puncture attempts are made.A decision is then made to reposition the spacer.The needle is removed with little resistance.When the spacer holder is removed, only the plastic part comes away from the patient, but not the cannula.This has fallen out of the plastic holder, but is not broken.It must be retrieved the following day in the operating theatre under bv control.The needle itself did not cause any serious injuries or consequences,and intraoperative removal under bv control was carried out without any problems.The patient underwent unnecessary general anaesthesia,which is not conducive to the further development of dementia or recovery of mental health.

• Brand Name: SPROTTE® LUMBAR
• Common Device Name: SPROTTE® LUMBAR 21G X 90MM
• 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: armin pfeifer ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 23109510
• Report Number: 9611612-2025-00043
• Device Sequence Number: 13285832
• Product Code: BSP
• UDI-Device Identifier: 04048223108611
• UDI-Public: 04048223108611
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K250774
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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?: Yes
• Device Catalogue Number: 321151-31A
• Device Lot Number: 1557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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