MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SOLERA VOYAGER 4.75; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6642002
Medical Device Problem Codes	Material Deformation (2976); Mechanics Altered (2984)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a set-screw using drivers for an olif, flipped posterior for perc screws.It was reported that the set screw drivers were all stripped and were not allowing for set screw to break off.They had several pans sterile that allowed them to finish the case via the back up pans.All 4 instruments were stripped and unable to break off the set screws.The patient is doing fine, they had several back up pans allowing them to finish the case.The patient was in contact with the instruments intra procedure, and there was a 25 min.Addition to the procedure because they had to go down to spd for their back up pans several times.There were no patient symptoms or complications as a result of the event.All drivers were replaced by medtronic products.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
H3: product analysis part# 6642002, lot# em16k037- visual and optical examination analysis revealed that the locking tabs have been bent inwards of the tip of the driver which will not allow the center shaft of the instrument to function and the retaining pin has been bent and the hex edges of the compressor have been rounded.This is consistent with bend stress overload.H6: updated patient code, eval.Code method, eval.Code result post analysis.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: SOLERA VOYAGER 4.75
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10668659
• Report Number: 1030489-2020-01419
• Device Sequence Number: 16798794
• Product Code: LXH
• UDI-Device Identifier: 00643169492455
• UDI-Public: 00643169492455
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 6642002
• Device Catalogue Number: 6642002
• Device Lot Number: EM16K037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1