MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE, SINGLE USE, PRODUCT CODE: BSP

Model Number	321151-31A
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event took place in (b)(6).Cannula broken during use.Part of 5cm remained in pt.Body.Removed under surgical intervention the next day.
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distributor.Currently the data available is poor.As soon as further information is received a follow up report will be sent to the agency.
Additional Manufacturer Narrative
Event took place in germany and has been reported through german distributor.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).Event took place in germany.Cannula broken during use.Part of 5cm remained in pt.Body.Removed under surgical intervention the next day.

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE, SINGLE USE, PRODUCT CODE: BSP
• 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, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 13166895
• Report Number: 9611612-2022-00001
• Device Sequence Number: 17180461
• Product Code: BSP
• UDI-Device Identifier: 04048223108611
• UDI-Public: 04048223108611
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K911260
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2026
• Device Model Number: 321151-31A
• Device Catalogue Number: 321151-31A
• Device Lot Number: 1392
• 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: 01/03/2022
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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: Required Intervention
• Patient Sex: Female