MAUDE Adverse Event Report: SPROTTE; SPINAL NEEDLE, SINGLE USE

Model Number	041251-29A
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6).Currently the data available is poor.As soon as we receive an update a supplemental report will be sent in to the agency.
Event or Problem Description
Irn# (b)(4).Tentative summarizing translation from initial reporter´s narrative: "during several attempts to place the needle in the spinal space at l2-l3 (after several unsuccessful attempts to place it in l3-l4) the needle broke at 3 cm during the removal procedure of the needle with its introducer.During the procedure i had never csf flow through the needle and we had no paresthesia.At the end the patient moves the legs without any sensitive or physical problems.We called the surgeon to try to surgically remove the tip of the needle with local anesthesia and sedation, after talking to the patient.Finally we succeeded in removing the needle".
Additional Manufacturer Narrative
Event took place in italy.Based on clinical assessment and risk assessment this file is considered as closed.
Event or Problem Description
Irn# (b)(4).Tentative summarizing translation from initial reporter´s narrative: "during several attempts to place the needle in the spinal space at l2-l3 (after several unsuccessful attempts to place it in l3-l4) the needle broke at 3 cm during the removal procedure of the needle with its introducer.During the procedure i had never csf flow through the needle and we had no parestesia.At the end the patient moves the legs without any sensitive or phisical problems.We called the surgeon to try to surgically remove the tip of the needle with local anesthesia and sedation, after talking to the patient.Finally we succeded in removing the needle".

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE, SINGLE USE
• MDR Report Key: 12030751
• Report Number: 9611612-2021-00009
• Device Sequence Number: 4165960
• Product Code: BSP
• UDI-Device Identifier: 04048223104316
• UDI-Public: 04048223104316
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 07/08/2024
• Device Model Number: 041251-29A
• Device Catalogue Number: 041251-29A
• Device Lot Number: 1310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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