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

Catalog Number	K17B
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
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.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.
Event or Problem Description
It was reported that patient underwent balloon kyphoplasty.Intra-op, when inflating the balloon the whole device(shaft + balloon) would rotate, the doctor held the shaft in place to get the directional balloon to inflate where desired.The tan portion that clips to the cannula was loose and would not hold the shaft in place.At this instance the balloon ruptured and as a result some contrast media leaked in the patient.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis:functional evaluation of the ibt balloon identified a sharp cut at the balloon, disallowing inflation.The morphology, location and timing of the balloon rupture is consistent with in vivo contact with sharp object, such as bone splinters.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXACT 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: 6652802
• Report Number: 2953769-2017-00073
• Device Sequence Number: 1285733
• Product Code: HRX
• UDI-Device Identifier: 00643169158146
• UDI-Public: 00643169158146
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/20/2017

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 Expiration Date: 02/28/2018
• Device Catalogue Number: K17B
• Device Lot Number: 0008511516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1