MAUDE Adverse Event Report: DEPUY SYNTHES SPINE GENERAL RETRACTOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

Gtin: unknown.On december 19, 2017, it was determined by the medical safety officer that the adverse event is likely related to the unknown retractor.As a result, a medwatch will be filed on the unknown device for the adverse event.All relevant information at the time of complaint closure was submitted in the initial medwatch for the (b)(6) trial.No further information is available at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned to manufacturer.

Event Description

During an anterior / posterior l4-5 fusion, surgeon placed a 10 mm cougar trial into the disc space and removed the trial handle to confirm proper placement with the c-arm.After imaging, surgeon could not re-attach the handle to the trial.After several attempts, another surgeon had to adjust his retractor to provide better visualization.The iliac vein tore and bled.Several clips were applied and bleeding was stopped.Surgeon removed the trial with a currette and placed the implant.Cancelled posterior portion of case.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GENERAL RETRACTOR
• Type of Device: RETRACTOR
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7161263
• MDR Text Key: 96900611
• Report Number: 1526439-2018-10000
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/09/2018
• 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): Other
• Patient Age: 61 YR