MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON LEGACY 5.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7480113
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2020
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) and distributor via a medtronic representative regarding a patient implanted with a screw using a driver for a lumbar spine arthrodesis.It was reported that the driver purchased by the distributor broke when tightening the screw during surgery (intra-op).There were no patient symptoms or complications as a result of the event.The patient came in contact with the product when the key broke while tightening the screw that was implanted in the patient.Only the key broke and there was no damage to the screw implanted in the patient.The pre- op diagnosis was lumbar hernia and the levels implanted were l4-l5 and l5-s1.There was no additional surgery/ necessitated intervention/ in- patient or extension of patient hospitalization.There was no injury as a result of the event.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
H3: product analysis part # 7480113, lot# pr7d001- visual inspection revealed the hex tip of the driver has been broken off.Microscopic examination of fracture surface reveals a brittle fracture surface no indication of fatigue or torsion.There is some damage to the first row of threads on the driver.The threaded portion of the driver sleeve is designed to mitigate instrument misalignment and associated bending stresses.This is consistent with not fully engaging the threaded portion of the driver sleeve into the mas head.This type of damage in 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: CD HORIZON LEGACY 5.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10539965
• Report Number: 1030489-2020-01290
• Device Sequence Number: 14210095
• Product Code: LXH
• UDI-Device Identifier: 00721902861468
• UDI-Public: 00721902861468
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 7480113
• Device Catalogue Number: 7480113
• Device Lot Number: PR17D001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1