MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC OTHER EXTRA-DISCAL; SCREWDRIVER

Model Number	815-518
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
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
Hold for r.G.1.20 information was received from user facility via field representative regarding patient with a pre-operative diagnosis of spinal canal stenosis involved in plif procedure.It was reported that at intra-op, when the set screw was tightened, it idled.There were no patient symptoms or complications as a result of this event.There were no additional treatment/surgery performed as a result of this event.There was delay in overall procedure time for less than 60 minutes.Event was associated with the patient.Initial reporter information is not provided due to the restriction by the privacy regulation.Levels implanted- l5/s received additional information that when the set screw for the solera 4.75 reduction screw was finally tightened, it was not kicked off using the reported driver.Another same driver was used and final tightening was able to be performed.The product came in contact with the patient as it was used in the wound.There were no mechanical/functional issues.The malfunction seemed to be some deformation.The exact malfunction was unable to be seen clearly due to the blood stains, but when it was checked after being cleaned, there was a clear deformation.
Additional Manufacturer Narrative
H3: product analysis part #: (b)(4), lot #: sw12a029.Visual inspection revealed, the torx edges of the instrument tip have been worn and deformed.Optical examination confirmed, the edges have been rounded off.This type of damage is consistent with torsional overload and repeated use overtime.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: OTHER EXTRA-DISCAL
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11184092
• Report Number: 1030489-2021-00079
• Device Sequence Number: 19702254
• Product Code: HXX
• UDI-Device Identifier: 00673978045092
• UDI-Public: 00673978045092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 815-518
• Device Catalogue Number: 815-518
• Device Lot Number: SW12A029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1