MAUDE Adverse Event Report: CARDINAL HEALTHCARE CORP CARDINAL HEALTH NEUROLOGICAL TRAY

Model Number SNECGSPAUD

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

The following elements have blank data.

Event Description

Patient was in operating room for a l4-5 anterior lumbar inter-body fusion performed by dr. As the surgeon was using #10 schwann morton knife blade on a long handle to dissect tissue off the vertebrae column, the knife blade broke in two pieces from the knife handle. This resulted with one piece falling to the side of the vertebrae where the surgeon had to remove tissue and suck blood carefully in order to identify the blade end that broke and safely remove it from the operating field. The other part of the blade remained on the knife handle and was safely removed from the field as well. Procedure was completed with no further incidents, knife blades from that spine pack from vendor schwann morton were all removed form the operating field and back table and replaced with a different manufacturer's knife blades. Vendor notified immediately upon incident reported by or nurse in the operating room. Manufacturer response for surgical disposable pack, pack surgical spine latex free (per site reporter). Email and phone call to area representative who filed the complaint with the company. The company removed all knife blades from schwann morton from this facilities' surgical spine packs and replaced them with a different manufacturer's knife blades per facility request, the replacement blade was requested to be thicker and sturdier to prevent breaking. Company also, notified facility that they would file an incident report with fda for the knife blades.

Event Description

Patient was in operating room for a l4-5 anterior lumbar inter-body fusion performed by dr. As the surgeon was using #10 schwann morton knife blade on a long handle to dissect tissue off the vertebrae column, the knife blade broke in two pieces from the knife handle. This resulted with one piece falling to the side of the vertebrae where the surgeon had to remove tissue and suck blood carefully in order to identify the blade end that broke and safely remove it from the operating field. The other part of the blade remained on the knife handle and was safely removed from the field as well. Procedure was completed with no further incidents, knife blades from that spine pack from vendor schwann morton were all removed form the operating field and back table and replaced with a different manufacturer's knife blades. Vendor notified immediately upon incident reported by operating room nurse in the operating room. Manufacturer response for surgical disposable pack, pack surgical spine latex free (per site reporter): email and phone call to area representative who filed the complaint with the company. The company removed all knife blades from schwann morton from this facilities' surgical spine packs and replaced them with a different manufacturer's knife blades per facility request, the replacement blade was requested to be thicker and sturdier to prevent breaking. Company also, notified facility that they would file an incident report with fda for the knife blades.

Event Description

Patient was in or for a l4-5 anterior lumbar inter-body fusion performed by dr. As the surgeon was using #10 schwann morton knife blade on a long handle to dissect tissue off the vertebrae column, the knife blade broke in two pieces from the knife handle. This resulted with one piece falling to the side of the vertebrae where the surgeon had to remove tissue and suck blood carefully in order to identify the blade end that broke and safely remove it from the operating field. The other part of the blade remained on the knife handle and was safely removed from the field as well. Procedure was completed with no further incidents, knife blades from that spine pack from vendor schwann morton were all removed form the operating field and back table and replaced with a different manufacturer's knife blades. Vendor notified immediately upon incident reported by or nurse in the operating room. Manufacturer response for surgical disposable pack, pack surgical spine latex free (per site reporter)
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email and phone call to area representative who filed the complaint with the company. The company removed all knife blades from schwann morton from this facilities' surgical spine packs and replaced them with a different manufacturer's knife blades per facility request, the replacement blade was requested to be thicker and sturdier to prevent breaking. Company also, notified facility that they would file an incident report with fda for the knife blades.

• Brand Name: CARDINAL HEALTH
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): CARDINAL HEALTHCARE CORP; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 6878649
• MDR Text Key: 260300806
• Report Number: 6878649
• Device Sequence Number: 1
• Product Code: OJG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/01/2019
• Device Model Number: SNECGSPAUD
• Device Catalogue Number: SNECGSPAUD
• Device Lot Number: 727298
• Other Device ID Number: #10 BLADE SCHWANN MORTON
• Was Device Available for Evaluation?: No Answer Provided
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2017
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 09/20/2017 Patient Sequence Number: 1

Treatment

NO OTHER DEVICE WAS BEING USED EXPECT A SELF RETAI; NO OTHER DEVICE WAS BEING USED EXPECT A SELF RETAI; NO OTHER DEVICE WAS BEING USED EXPECT A SELF RETAI; NO OTHER THERAPIES; NO OTHER THERAPIES; NO OTHER THERAPIES; NO OTHER DEVICE WAS BEING USED EXPECT A SELF RETAI; NO OTHER THERAPIES