MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE®; SPROTTE® _NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number	121151-27A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Irn#(b)(4) incident occurred in germany: original text german: punktion lege artis, dabei bruch der nadel direkt hinter der führungskanüle.Zu keiner zeit erhöhter kraftaufwand, nadel nach entfernung durch chirurg nicht verformt.Translated into english: puncture lege artis, needle breakage directly behind the guide cannula.No increased force required at any time, needle not deformed after removal by surgeon.
Additional Manufacturer Narrative
Irn# (b)(4) complaint took place in germany.The necessary placeholders for packing the initial report by the submitter in h6, code b, c and d can still change in the final report.The reported incident is currently still being processed.The test results will be provided in the following report.
Additional Manufacturer Narrative
(b)(4).Complaint took place in germany.The necessary placeholders for packing the initial report by the esubmitter in h6, code b, c and d can still change in the final report.Changes in these fu1 document under h6 compared to the initial message.B-code: 10.C-code: 4243.D-code: remains as in initial message.E-code: 2687.F-code: 4625.Based on clinical assessment and risk assessment this case is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
(b)(4).Incident occurred in germany: original text german: punktion lege artis, dabei bruch der nadel direkt hinter der führungskanüle.Zu keiner zeit erhöhter kraftaufwand, nadel nach entfernung durch chirurg nicht verformt.Translated into english: puncture lege artis, needle breakage directly behind the guide cannula.No increased force required at any time, needle not deformed after removal by surgeon.

• Brand Name: SPROTTE®
• Common Device Name: SPROTTE® _NEEDLE, CONDUCTION, ANESTHETIC (W/WO 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: 21303033
• Report Number: 9611612-2025-00001
• Device Sequence Number: 8084100
• Product Code: BSP
• UDI-Device Identifier: 04048223107096
• UDI-Public: 04048223107096
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 121151-27A
• Device Catalogue Number: 121151-27A
• Device Lot Number: 1543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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: Female