MAUDE Adverse Event Report: DEPUY SYNTHES SPINE INNER SET SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 188342200

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

O-c5 instrumentation using mountaineer was performed on (b)(6) 2015.During the linking procedure of the connector, the surgeon tried to finally tighten a setscrew while pressing the rod, but it was spinning idly and a metal piece was produced.The surgeon used a snp connector and another setscrew instead and completed the procedure with a 10-minute delay.According to the surgeon, the insertion angle of the setscrew became off-axis in the middle of the insertion and it was a problem of the connector¿s design.There were no adverse consequences to the patient.

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

Device was not returned for evaluation.A review of the device history record could not be conducted as the lot number is unknown.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.Device not returned.

• Brand Name: INNER SET SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767 CH-
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4634328
• MDR Text Key: 5757742
• Report Number: 1526439-2015-10220
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK041203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2015

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: 188342200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 03/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2015
• 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
• Patient Sequence Number: 1