MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; SCREWDRIVER

Model Number	5480004V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Intra op, driver's tip broke off when attempting to remove the screw.The broken tip of the driver is remaining in the screw left in the patient's body.Two screws remain in the l5 vertebral body.There was a delay of 30 min in overall procedure.
Additional Manufacturer Narrative
H3: part # 5480004v lot # fa11c003 visual examination confirmed approximately 4mm of the instrument tip has been broken off and not returned for analysis.Optical inspection of the fracture surface revealed a fairly flat ductile fracture with circular material flow, consistent with torsional overload.Material hardness confirms conformance to print specifications.This type of damage is consistent with torsional overload.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10162122
• Report Number: 1030489-2020-00661
• Device Sequence Number: 2653868
• Product Code: HXX
• UDI-Device Identifier: 00643169501133
• UDI-Public: 00643169501133
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143375
• 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): 09/14/2020

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: Health Professional
• Device Model Number: 5480004V
• Device Catalogue Number: 5480004V
• Device Lot Number: FA11C003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1