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

Model Number 041251-29A

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/27/2021

Event Type  malfunction  

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 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".

Manufacturer Narrative

Event took place in italy.Based on clinical assessment and risk assessment this file is considered as closed.

Event 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
• Type of Device: SPINAL NEEDLE, SINGLE USE
• MDR Report Key: 12030751
• MDR Text Key: 257232043
• Report Number: 9611612-2021-00009
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223104316
• UDI-Public: 04048223104316
• Combination Product (y/n): N
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 041251-29A
• Device Catalogue Number: 041251-29A
• Device Lot Number: 1310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other