MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CAGE TRIAL, SMALL; TEMPLATE

Catalog Number 273205110

Device Problem Difficult to Insert (1316)

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

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During an anterior / posterior l4-5 fusion, surgeon placed a 10mm 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

During a post market review, the medical safety officer determined this device did not cause or contribute to the reported event.It is considered a concomitant device.The unknown retractor was determined to be related to the reported event and therefore, a medwatch will be submitted for the unknown retractor.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was not returned for evaluation.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.Without the returned of the device we are unable to confirm the reported issue or identify the root cause.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Visual examination of the returned device found the threads inside the cage were missing entirely.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the trial cage¿s threads being torn cannot be determined from the samples and the information provided.A potential root cause may be cross threading the inserter tip upon insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CAGE TRIAL, SMALL
• Type of Device: TEMPLATE
• 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: 6629677
• MDR Text Key: 77234564
• Report Number: 1526439-2017-10419
• Device Sequence Number: 1
• Product Code: HWT
• 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,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 273205110
• Device Lot Number: TBKFO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR