MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON V OSTEO INTRODUCER 11 GA TROCAR/BEVEL KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPK011D
Medical Device Problem Codes	Difficult to Remove (1528); Mechanics Altered (2984)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
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) via a medtronic representative regarding a patient implanted with a spinal product using a trocar for a sacroplasty.It was reported that the head of the trocar became loose at the connection to the metal and could not be removed from the patient without excessive force and tools to grip the metal.There were no complications during the procedure except that an additional product needed to be opened to complete the procedure.There were no patient symptoms or complications as a result of the event.The patient came in contact with the product.The pre-op diagnosis was sacral fracture.Level implanted was sacrum.After having major difficulty pulling out the trocar, we had to use a t34a and cds2a and cc02a to complete the procedure.The product was replaced by a medtronic product.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
H3: product analysis; part# vpk011d, lot# 0219666331: visual and optical inspection revealed the trocar is jammed in the shaft due to the dried cement.There are no signs of the shaft separating from the hub.Root cause of issue undetermined.H6: updated eval.Code method, patient code, 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: KYPHON V OSTEO INTRODUCER 11 GA TROCAR/BEVEL KIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10776944
• Report Number: 1030489-2020-01566
• Device Sequence Number: 1126724
• Product Code: LXH
• UDI-Device Identifier: 00643169637504
• UDI-Public: 00643169637504
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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 Expiration Date: 12/19/2020
• Device Model Number: VPK011D
• Device Catalogue Number: VPK011D
• Device Lot Number: 0219666331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1