MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SABER CAGE 11*10*25; SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM

Catalog Number 187225010

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2014

Event Type  malfunction  

Event Description

International affiliate reports that when the surgeon wanted to fill the cage with the patient's bone, the bone piece was too big.He therefore used a hammer to insert the bone piece.The cage cracked where the implant driver is supposed to be screwed and another cage was used to complete the surgery.The difficulty resulted in a five to ten minute delay to the procedure.No patient was impact was reported.

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

The 11x10x25mm saber cage was returned for evaluation.Visual inspection found fractures on both the left and right hand sides of the threaded hole.A review of the device history record (dhr) identified no issues during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A 12 month review of the complaint trend analysis for the saber cage was performed on the cage¿s specific product code from the complaint as the change in dimensions across the product family change the fracture profile for the cage.This analysis found no related complaints.The root cause cannot be determined from the sample and information provided.According to the original event description, a larger-than-average piece of bone was used to fill the cage.This piece was inserted via a hammer.A potential root cause is force applied to a bone fragment too large to fit inside of the cage via the insertion method used.The force of the hammer transferred to the cage through the bone fragment, causing the fracture in the cage.No corrective and preventive action (capa) is necessary at this time as there has been no issue identified in the manufacturing or release of this device.Therefore, this complaint 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.

• Type of Device: SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 38 chemin blanc; lelocle CH-2 400; SZ CH-2400
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3999320
• MDR Text Key: 4709729
• Report Number: 1526439-2014-11755
• Device Sequence Number: 1
• Product Code: MCV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP960025:011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 187225010
• Device Lot Number: AKNB2J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2009
• 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