MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MOSS MIAMI; DRIVER, PROSTHESIS

Model Number	275015900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/31/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned for evaluation.
Event or Problem Description
Surgeon informed me about the viper surgery he performed on (b)(6) 2017.The female patient had been provided with 5 viper screws on each side.Since only 8 extensions were available in the set, the surgery was performed in a kind of mini open technique.One screw on each side was placed without an extension.Besides 2 extension disassembled during the surgery and 2 screws each side were placed without extensions.When the rod placing was finished (rod well pre-bended), the innies were placed.The rod couldn't be placed far enough into the screw head and the innie couldn't be tightened.Therefore plunger (code no.275015900) mm rod introduction instrument was used.Surgeon tried to place the rod with the plunger into the screw head in order to be able to tighten the innie.In doing this the surgeon slipped off the rod and the patient's aorta was injured.The patient died.

• Brand Name: MOSS MIAMI
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6907298
• Report Number: 1526439-2017-10779
• Device Sequence Number: 745222
• Product Code: HWR
• UDI-Device Identifier: 10705034194455
• UDI-Public: (01)10705034194455
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 09/06/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 275015900
• Device Catalogue Number: 275015900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death