MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PROVISIONAL DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7480131
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
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
Medtronic received information regarding navigation and spinal instruments being used intra-operatively of a spinal l4/5 stenosis procedure.It was reported that the legacy ratchet and provisional break off.The ratchet handle broke.They did not break inside the patient anatomy.There was no impact on the patient income.Additional information was received stating that all three instruments were all broken.The provisional would no longer retain the break off screws.The ratchet handles were no longer working.The caps on top fell off.
Additional Manufacturer Narrative
H2) visual and optical examination identified that the locking end tip of the shaft is worn from what appears to be from repeated normal use.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: PROVISIONAL DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10962037
• Report Number: 1030489-2020-01751
• Device Sequence Number: 2419219
• Product Code: LXH
• UDI-Device Identifier: 00721902853579
• UDI-Public: 00721902853579
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 7480131
• Device Catalogue Number: 7480131
• Device Lot Number: PR12B007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1