MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE MODIFIED INSTRUMENT DRIVER; DRIVER, PROSTHESIS

Catalog Number	698336615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2017
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
The surgeon had a c2-6 posterior cervical case using mountaineer.While the surgeon was putting in a t1 screw, the mountaineer qc poly driver (6983-36-615 lot# gm3537601) tip snapped.The tip broke off in the screw head but luckily the surgeon was able to retrieve it.The surgeon pulled the broken tip out and inserted the screw the rest of the way with a different screwdriver.The broken tip of the screwdriver was retrieved successfully and placed on the back table for the remainder of the case.The procedure was completed successfully and without patient harm.
Additional Manufacturer Narrative
Visual examination of the returned device found the distal tip was broken.Optical imaging revealed torsional shear markings suggesting a quasi-static torsional shear overload.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.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the driver¿s distal tip becoming broken cannot be positively determined.However, the fracture analysis report suggests that the driver underwent a quasi-static torsional shear failure.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODIFIED INSTRUMENT DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6827737
• Report Number: 1526439-2017-10720
• Device Sequence Number: 19111837
• Product Code: HWR
• UDI-Device Identifier: 10705034374338
• UDI-Public: (01)10705034374338
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/14/2017

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 Catalogue Number: 698336615
• Device Lot Number: GM3537601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 10/03/2017
• Patient Sequence Number: 1