MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; SCREWDRIVER

Model Number	5484336
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	08/03/2020
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 manufacturer representative regarding a patient having tlif(transforaminal lumbar interbody fusion) on l4/5 and plif(posterior lumbar interbody fusion) on l5/s1 due to l4 spondylolisthesis, l5 isthmic spondylolisthesis, lumbar spinal canal stenosis.It was reported that reduction set screw was inserted, rod was placed, reduction operation was performed with driver, when the final tightening was performed, force was applied as it was and the tip of the driver broke.The broken tip remained on set screw before performing the break-off for set screw, so the set screw was removed by the pliers of hospital, and it was replaced with a new set screw, the final tightening was performed and the procedure was completed.There were no patient symptoms/complications reported as a result of this event.There was an overall procedure delay of less than 60 mins.The product was replaced and will be returned.There was no fragment remained in the patient¿s body.No further complications were reported.
Additional Manufacturer Narrative
H3:product analysis: 5484336, lot: rs19j018 visually confirmed approximately ~3mm of instrument tip has been broken off, consistent with interface during usage.Fracture surface analysis reveals a fairly flat fracture surface and circular material movement.The above findings are 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: CD HORIZON SPINAL SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10435631
• Report Number: 1030489-2020-01119
• Device Sequence Number: 2743978
• Product Code: HXX
• UDI-Device Identifier: 00613994946591
• UDI-Public: 00613994946591
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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: 5484336
• Device Catalogue Number: 5484336
• Device Lot Number: RS19J018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1