MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the reported complaint of a balloon rupture was confirmed during use.Visual examination identified tears near the proximal peak of the balloon.This observation is consistent with rupture due to contact with bone splinters during instrument usage.The above observations are consistent with intraoperative instrument damage.Additional balloon expander was sent back with an inflation issue.The balloon would not expand.It appeared to be clogged up.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, intra-op, the balloon burst at 200 psi.The procedure was completed with another device.There was a delay in the surgery.The device came in contact with the patient.No patient complications were occurred due to this event.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo cucapah # 10510; parque industrial ei lago; tijuana ; MX
• MDR Report Key: 8128011
• Report Number: 9612164-2018-03458
• Device Sequence Number: 1244348
• Product Code: HRX
• UDI-Device Identifier: 00643169103061
• UDI-Public: 00643169103061
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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: K09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1