MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON UNIVERSAL TOOLS-ACCESSORIES; MIXER, CEMENT, FOR CLINICAL USE

Model Number A07A

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using a mixer for an unknown spinal indication (intra-op).It was reported that, when an attempt was made to mix cement with mixer combined with the head attached with paddle, the paddle seemed to be bent, and it could not enter deeply, so cement couldn't be mixed.When a new mixer was opened and combined with a head attached with a paddle, it was able to mix properly.Cement monomer and polymer were put in mixer and an attempt was made to insert a paddle to mix cement, but it felt like it got stuck and the paddle could not be inserted.After pushing the paddle in, an attempt was made to rotate it, but it still got stuck and cement could not be mixed, so a new product was opened and a new paddle was used, it was able to work without problems.The event was not associated with a patient, hence there were no patient symptoms or complications as a result of the event.The levels implanted were t11.The product had been discarded on the spot due to cement or blood adhesion.No further complications were reported/ anticipated.

Manufacturer Narrative

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.

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using a mixer for a balloon kyphoplasty (bkp).It was reported that, when an attempt was made to mix cement with mixer combined with the head attached with paddle, the paddle seemed to be bent, and it could not enter deeply, so cement couldn't be mixed.When a new mixer was opened and combined with a head attached with a paddle, it was able to mix properly.Cement monomer and polymer were put in mixer and an attempt was made to insert a paddle to mix cement, but it felt like it got stuck and the paddle could not be inserted.After pushing the paddle in, an attempt was made to rotate it, but it still got stuck and cement could not be mixed, so a new product was opened and a new paddle was used, it was able to work without problems.The event was not associated with a patient, hence there were no patient symptoms or complications as a result of the event.The product was not used in patient.The patient did not come in contact with the reported product.The levels implanted were t11.The product had been discarded on the spot due to cement or blood adhesion.No additional surgery was performed.The product was replaced by a medtronic product.No further complications were reported/ anticipated.

Event Description

Mdr decision corrected to not reportable.No additional supplementals are required unless additional information received indicates reportable event.

Manufacturer Narrative

H1: review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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 UNIVERSAL TOOLS-ACCESSORIES
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10639935
• MDR Text Key: 214148694
• Report Number: 1030489-2020-01388
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: A07A
• Device Catalogue Number: A07A
• Device Lot Number: 0010292185
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/12/2020; 09/17/2020
• Supplement Dates FDA Received: 10/15/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1