MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SI CANNULATED POLYAXIAL SCREW 5.5 X 7.00 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186715735

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/27/2015

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

L5-s1 instrumentation using viper2 was initially performed on a patient with spondylolisthesis on (b)(6) 2013.Then the left screw was broken 1 year after the surgery and the right screw was broken in this april.As the bone adhesion was confirmed, the screw removal surgery was performed on (b)(6) 2015.All broken pieces left in the patient body were removed by pliers for schantz screw.The surgery was successfully completed with a 30 minute delay.According to the physician, the patient took exercise so hard on a daily basis as a softball catcher of the national champion team that the screw might have been broken.In addition, she was so young that the screws were not loosened from the bone.

Manufacturer Narrative

Two (2) viper mis cannulated 7x35mm top loading poly screws [product code: 1867-15-735, lot no: anldtj] were returned to the complaints handling unit (chu) for evaluation.Visual examination revealed that the samples broke at the transition zone between the screws¿ polyaxial spheres and the screw shanks.The fracture analysis report indicated that the fractured surfaces of the samples exhibited smooth and grainy/rough regions, indicative of fatigue failures.No material defects or other abnormalities were observed in this analysis.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.No emerging trends were found requiring further actions the root cause for the polyaxial screws breaking cannot be positively determined.However, the fracture analysis report indicated that the fractured surfaces of the samples exhibited smooth and grainy/rough regions, indicative of fatigue failures.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 requiring immediate action have been observed, 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: SI CANNULATED POLYAXIAL SCREW 5.5 X 7.00 X 35MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5315931
• MDR Text Key: 34037380
• Report Number: 1526439-2015-11077
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2015

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?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186715735
• Device Lot Number: ANLDTJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/27/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 17 YR