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

Model Number	815-518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
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 healthcare provider (hcp) via a manufacturer representative regarding an event happened during intra-op of the reported products.The pre-op diagnosis was mentioned as congenital scoliosis.The procedure or technique performed was posterior fusion.It was reported that, when an attempt was made to loosen the mrc set screw used during the last time operation, the tip of the reported torx shaft was broken.Later, obturator was used to remove the screw but the tip of obturator bent.The reported event was happened during revision surgery.It is a two stage surgery for congenital scoliosis.Last time it was l3-5 posterior fusion, this time posterior fusion at t3-t12 and rod connect were performed.There were no symptoms to patient or physician were reported.There were no broken fragments of instrument remains in patient.The levels implanted were t3-t12.No further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis of part#815-517 ; lot# sw13h005 analysis summary: visual examination confirmed approximately 3mm of instrument tip has been broken off, consistent with interface during usage.Optical examination of the fracture surface identified a fairly flat fracture surface and circular material displacement.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: OTHER EXTRA-DISCAL
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13140358
• Report Number: 1030489-2022-00002
• Device Sequence Number: 4666851
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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: SW13H005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male