MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L DE C.V. KYPHON EXPRESS; ARTHROSCOPE

Catalog Number	KE202
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not 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
Pre-operative diagnosis: osteoporosis with vertebral compression fractures it was reported that intra-op, balloon tore and was stuck against the working cannula that had slightly bent on introduction as the bone was sclerotic.Balloon would not pull out so the entire cannula was removed and this released the balloon.The trocar was reintroduced and the procedure was completed successfully with the original product.No patient complications occurred as a result of the event.

• Brand Name: KYPHON EXPRESS
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L DE C.V.; avenida paseo cucapah # 10510; parque industrial ei lago; tijuana 22570 ; MX 22570
• MDR Report Key: 7841127
• Report Number: 9612164-2018-02264
• Device Sequence Number: 11097192
• Product Code: HRX
• UDI-Device Identifier: 00643169143753
• UDI-Public: 00643169143753
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• 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
• Report Date (Section B): 09/04/2018

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 Catalogue Number: KE202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1