MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE®; SPROTTE®_SPINAL NEEDLE, SINGLE-USE

Model Number	021151-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Irn# (b)(4).Original text / german: herr dr.W wollte eine spa stechen.Dies war frustran.Die zielstruktur wurde nicht erreicht.Beim ziehen der nadel ist diese gebrochen und ca.5cm sind im patienten verblieben.(die sectio erfolgte in vollnarkose ohne probleme) herr r.W beschreibt die punktion ohne jede probleme oder knochenkontakt.Warum die nadel beim durchdringen der weichteile gebrochen ist, ist völlig unklar.Translated into english: dr.W.Wanted to prick a spa.This was without effect.The target structure was not reached.When the needle was pulled out, it broke and approx.5 cm remained in the patient.(the section was performed under general anaesthesia without any problems) mr.R.W.Describes the puncture without any problems or bone contact.It is completely unclear why the needle broke when penetrating the soft tissue.
Additional Manufacturer Narrative
Event took place in germany.The facts of the case, relevant tests are currently in process.In case new information becomes available a follow up report will be sent to the agency.
Additional Manufacturer Narrative
Event took place in germany.Based on clinical assessment and risk assessment this event is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4).Tentative translation to english: dr.(b)(6) wanted to prick a spa.This was without effect.The target structure was not reached.When the needle was pulled out, it broke and approx.5 cm remained in the patient.(the section was performed under general anaesthesia without any problems) mr.R.W.Describes the puncture without any problems or bone contact.It is completely unclear why the needle broke when penetrating the soft tissue.

• Brand Name: SPROTTE®
• Common Device Name: SPROTTE®_SPINAL NEEDLE, SINGLE-USE
• 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.; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str; geisingen, 78187 ; GM 78187
• MDR Report Key: 20134832
• Report Number: 9611612-2024-00018
• Device Sequence Number: 15278177
• Product Code: BSP
• UDI-Device Identifier: 04048223114681
• UDI-Public: 04048223114681
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 021151-29A
• Device Catalogue Number: 021151-29A
• Device Lot Number: 1519
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female