MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON CEMENT DELIVERY SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPK013D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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 the healthcare professional (hcp) via the manufacturer representative regarding an event which occurred during an unknown spinal procedure in a patient diagnosed with osteoporosis.It was reported that the cannula hub came off during extraction at the end of procedure.Physician used forceps to pull cannula shaft from pedicle.Only the shaft of the instrument will be returned.Handle was thrown away accidentally.Event occurred during vertebroplasty - after cement fill, physician tried to extract cannula.Handle twisted/pulled off.Cannula stayed in patient.Used strong/ large hemostat forceps to pull cannula out of vertebral body.No fragment left in patient.No patient injury / complication was reported.
Additional Manufacturer Narrative
H3: product analysis: part # vpk013d, lot # 0221000818.Visual and optical inspection confirmed the cannula was returned with the hub pulled from the shaft.The plastic handle/hub portion of the instrument was not returned.On the cannula, the knurling was present as well as the flair on the backside of the shaft.There was cement noted inside the inner shaft.It appears the shaft was separated from the plastic hub from excessive force.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 CEMENT DELIVERY SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11587278
• Report Number: 1030489-2021-00415
• Device Sequence Number: 19879327
• Product Code: LXH
• UDI-Device Identifier: 00643169637498
• UDI-Public: 00643169637498
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 09/04/2021
• Device Model Number: VPK013D
• Device Catalogue Number: VPK013D
• Device Lot Number: 0221000818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2021
• Supplement Date Received by Manufacturer: 09/25/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 54