MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE MIS CANNULATED CORTICAL FIX X-TAB 6X35MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186760135
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.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 or Problem Description
On (b)(6) 2017, surgery was performed using the xtab/cfs system.The fixed are was l2-sai.At the time of inserting the screw using the cbt trajectory method, the surgeon failed to snap the tab well, thus a burr was left on the tab and the thread deformed.Finally, he could not attach the screw onto the driver.He dealt with this event by replacing the screw in question with a new one.There are no broken parts found left in the body.The surgery was successfully completed with a 5-minute delay, and there was no adverse consequence to the patient.No additional information has been provided from the hospital.
Additional Manufacturer Narrative
The cortical fix x-tab screw was returned for evaluation.Visual inspection revealed that part of the thread is deformed and peeled out.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot be positively determined however it is possible that an incomplete tab break lead to the deforming and peeling of the thread.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 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: MIS CANNULATED CORTICAL FIX X-TAB 6X35MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6798386
• Report Number: 1526439-2017-10670
• Device Sequence Number: 19003998
• Product Code: NKB
• UDI-Device Identifier: 10705034465449
• UDI-Public: (01)10705034465449
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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
• Operator of Device: Physician
• Device Model Number: 186760135
• Device Catalogue Number: 186760135
• Device Lot Number: TBRRL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/20/2017
• Patient Sequence Number: 1