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

Model Number	5584099
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
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 healthcare professional via field representative regarding patient with revision and extension of a spondy involved in fusion therapy.Levels implanted: l4/s1 it was reported during procedure, the screwdrivers broke off when inserting the solera screws.It had 2 screwdrivers in the tray.The second screwdriver also broke.There was no fragments of broken instrument left in patient's body.Event was revision surgery.The surgeon removed all legacy screw, not relevant for the broken screwdriver.Products were replaced.There was no delay in overall procedure time.There is no treatment or additional surgery performed as a result of the event.There is no patient symptoms or complications reported as a result of the event.On (b)(6) 2020, received additional information that patient had pain, so revision surgery was performed.Surgeon replaced legacy screws with solera screws.Reported there were no problems with legacy screws.Reported two screwdrivers broke when inserting solera screws even when the patient had hard bone.Patient is alive and no injury.
Additional Manufacturer Narrative
H3: device evaluated summary - visual inspection confirmed the entire torx tip of instrument has been sheared off.Optical examination of the fracture surface revealed a fairly flat fracture surface with circular material flow, consistent with torsional overload.This type of damage is consistent with torsional overload.Additional information - d9, g3, h3, h6.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.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: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10764328
• Report Number: 1030489-2020-01521
• Device Sequence Number: 11559546
• Product Code: LXH
• UDI-Device Identifier: 00643169163065
• UDI-Public: 00643169163065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/15/2021

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: 5584099
• Device Catalogue Number: 5584099
• Device Lot Number: SW19H018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 03/13/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR