MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 3D CROWN MAYFIELD SLIDER ASSY; COMPONENT, TRACTION, INVASIVE

Catalog Number 292301030

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

International affiliate reports the connector part of the 3d crown mayfield slider assembly and the halo adaptor set for mayfield had been broken and the devices could not be assembled to each other when the surgeon tried to use them at the beginning of the surgery.The surgery was planned to be processed with a halo vest for the patient who had cervical fracture.However, the products could not be used and the surgeon completed the cervical internal fixation surgery without the halo vest.See mfg medwatch report no 1526439-2014-11309 for the halo adaptor set for mayfield that was involved in the event.

Manufacturer Narrative

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.

Manufacturer Narrative

Visual inspection of the 3d slider adapter revealed that the 1/4-28 unf ¿ 2b hole showed signs of peeled threads and thread deformation at the entry point which is consistent with cross-threading.A review of the device history record for the 3d slider adapter no discrepancies during the manufacturing of the product.No issues were identified during the manufacturing and release of this product that could have been contributed to the problem reported by the customer.The product was released accompanying all quality requirements.A 12 month review of the complaint trend analysis for the 3d slider adapter and mayfield adapter set was conducted on the specific codes from the complaint as a device family does not exist for these instruments.It was noted that there were no related complaints for the inability to assemble the 3d slider adapter to the mayfield adapter or vice versa.The results of this trending suggest that this is an isolated event.Review of complaints found no significant trends.The root cause is unknown however it is likely that as the 3d slider adapter was being attached to the mayfield adapter, the connection became cross threaded resulting in the inability for these components to be fully assembled.No corrective action/preventive action is required as there has been no issue identified in the manufacturing or release of this device, and there have been no systematic trends.Therefore, this complaint will be closed with no further action required.

• Brand Name: 3D CROWN MAYFIELD SLIDER ASSY
• Type of Device: COMPONENT, TRACTION, INVASIVE
• 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: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3645397
• MDR Text Key: 4285108
• Report Number: 1526439-2014-11308
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 292301030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 02/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HALO VEST