MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K08A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation; therefore, we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with spinal fracture underwent kyphoplasty.Intra-op, the inflatable bone tamp(ibt) ruptured.The ibt ruptured during first inflation at a pressure below 300 psi.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: during functional analysis, it was not possible to inflate the balloon due to a hole or leak on the ibt.Visual analysis confirmed that there is a hole on the balloon.This is a radial hole on the distal peak of the balloon conclusion: based on the information provided, functional and visual analysis, the most probable root cause of the rupture of the balloon is attributed to the contact of the balloon with bone splinters during surgery.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 XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• MDR Report Key: 6342645
• Report Number: 2953769-2017-00016
• Device Sequence Number: 1001728
• Product Code: HRX
• UDI-Device Identifier: 00858196001154
• UDI-Public: 00858196001154
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

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: K08A
• Device Lot Number: 0008250402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1