MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON V BONE BIOPSY DEVICE

Catalog Number	VPB13D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
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
It was reported that the patient presented with suspected bone tumor; and underwent bone biopsy.Intra-op, the hub from the biopsy device came off when it was tried to get a specimen.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: 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 no signs of cement inside the inner diameter of the hub.The shaft had been bent and damaged possibly from the removal process.It appears the shaft was separated from the plastic hub by excessive force.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON V BONE BIOPSY DEVICE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9831648
• Report Number: 9612164-2020-01167
• Device Sequence Number: 2421985
• Product Code: MJG
• UDI-Device Identifier: 00763000026769
• UDI-Public: 00763000026769
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/18/2020

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 Expiration Date: 04/11/2021
• Device Catalogue Number: VPB13D
• Device Lot Number: 217473733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1