MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NEURO PACK

Catalog Number	DYNJ0397191T
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a spinal fusion, a #11 surgical blade (taken from a neuro pack) broke in half.At the time of the incident, the surgeon was reportedly cutting the disc in the spine when the blade broke in half off of the scalpel.The surgeon was able to remove the blade; however the removal added an additional 20-30 minutes and x-rays were required to remove the sharp pointed end out of the patient's spine.Per the facility's report, all pieces of the blade were successfully retrieved without further incident.No impact to the patient, the staff, or the procedure was reported.There was no serious injury or follow-up care reported related to the event.General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.Due to the reported event and required medical intervention, this medwatch is being filed.The sample was not returned to the manufacturer for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the surgical blade broke in half.The blade was successfully retrieved without further intervention.

• Common Device Name: NEURO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8475203
• Report Number: 1423395-2019-00007
• Device Sequence Number: 1104281
• Product Code: OJG
• UDI-Device Identifier: 10889942495191
• UDI-Public: 10889942495191
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: No Information
• Device Catalogue Number: DYNJ0397191T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention