MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE MIS CANNULATED CORTICAL FIX X-TAB 7X50MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186770150
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
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
Upon insertion of the viper cortical fix xtab screw (7x50) the head broke free from the screw.We noted on the xray that the screw was not fully seated in bone or wedged between the facet however the screw shank went through the bottom of the tulip head.The saddle remained inside the screw head and the screw was removed without incident using the standard screwdriver.
Additional Manufacturer Narrative
The cortical fix x-tab screw was returned for evaluation.Visual inspection revealed that the screw head was disassembled from the screw shank.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 definitively determined however the noted damage suggests that the screw may have been subjected to unanticipated forces during screw placement.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 7X50MM 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: 6764898
• Report Number: 1526439-2017-10628
• Device Sequence Number: 11266137
• Product Code: NKB
• UDI-Device Identifier: 10705034465807
• UDI-Public: (01)10705034465807
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: 186770150
• Device Catalogue Number: 186770150
• Device Lot Number: TBRDP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 09/11/2017
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 104