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

Catalog Number DYNJ0397191T

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

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 Description

It was reported that the surgical blade broke in half.The blade was successfully retrieved without further intervention.

• Type of Device: NEURO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8475203
• MDR Text Key: 145771490
• Report Number: 1423395-2019-00007
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10889942495191
• UDI-Public: 10889942495191
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJ0397191T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention