MAUDE Adverse Event Report: PERFUSION SYSTEMS KYPHON V OSTEO INTRODUCER 13GA TROCAR/BEVEL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPT13D
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	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via manufacturer representative regarding a patient with an unknown indication in need of sacroplasty used in spinal therapy.It was reported that the handle broke loose during the malleting into the sacrum.There was a 5 min delay to try to get the needle out with needle driver. there were no patient symptoms reported.There were no fragments in the patient reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Device evaluation summary: visual and optical inspection confirmed, the cannula was returned with the hub pulled from the shaft.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 diameter of the hub.The plastic handle was not returned with the 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 V OSTEO INTRODUCER 13GA TROCAR/BEVEL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10768830
• Report Number: 2184009-2020-00073
• Device Sequence Number: 11291129
• Product Code: LXH
• UDI-Device Identifier: 00763000026820
• UDI-Public: 00763000026820
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: 11/13/2021
• Device Model Number: VPT13D
• Device Catalogue Number: VPT13D
• Device Lot Number: 218856893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1