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

Model Number	021163-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation report file is considered as closed.
Event or Problem Description
Irn#: (b)(4).Whilst performing a spinal anaesthetic procedure, the needle fell apart in the anaesthetists hands meaning that a section of the needle was left behind in the patient.All but 5mm of the 90mm needle was left inside the patients back (spine).First attempt at spinal, deep bony resistance encountered.Needle engaged in ligament as would be expected.Needle withdrawn to be repositioned.Noticed that needle appeared incomplete.Only stylet appeared to be visible on withdrawal, without accompanying needle.Needle fracture seen clearly at hub.Fractured needle seen protruding from patient.Request made for scrub kit, in particular artery forceps.Needle firmly grasped and removed, without excessive force intact and straight.Pictures taken.Retained for examination.On examination, needle appears intact.Sprotte tip of needle clearly seen, with straight shaft and clear shear point at hub.Low probability of retained item.Patient allowed to sit up and reassured.Further spinal attempted at lower interspace on second attempt.Details of injury (to patient, carer or healthcare professional): no injuries noted to the patient or the health professional.The anaesthetist managed to grasp the 5mm protruding from the patients skin with a small pair of forceps and removed it safely.He was happy that all components were present and nothing was left in the patient.As a precaution a ct scan was carried out on the advice of the on call radiologist.

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE, SINGLE USE
• MDR Report Key: 11989381
• Report Number: 9611612-2021-00006
• Device Sequence Number: 10993916
• Product Code: BSP
• UDI-Device Identifier: 04048223052679
• UDI-Public: 04048223052679
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2025
• Device Model Number: 021163-29A
• Device Catalogue Number: 021166-29A
• Device Lot Number: 1344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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