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

Catalog Number	K13A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2016
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.
Event or Problem Description
It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty at l1 for burst fracture.Intra-op, the balloon did not inflate.It was pulled out from patient¿s body once and checked.The inflation had no problem but it was found that balloon was filled with air.The balloon inflated 2ml but the air occupied about half of the space.The incision was closed with inflation and filling of cement on only one side.After the surgery, balloon was checked and a small hole ,which was not able to be seen visually, was found at the base of the balloon (it was found because leakage of contrast media was observed).Product came in contact with the patient.There was a delay of less than 60 mins in overall procedure time as a result of this event.No fragment of the device remained in the patient.No patient complications were reported.Doctor commented that the event was expected because the patient¿s bone was hard.
Additional Manufacturer Narrative
Product analysis :one balloon returned for analysis.Visually the balloon appeared to be used but undamaged.Functional test: a sample syringe was filled with liquid, and then were injected into the returned ibt.The instrument was then pressurized.Pin-hole leak was noted at the base of the y-valve.No leak was noted on the ibt balloon.The root cause of leak at the valve is undetermined.
Additional Manufacturer Narrative
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: 6244736
• Report Number: 2953769-2017-00003
• Device Sequence Number: 844443
• Product Code: HRX
• UDI-Device Identifier: 00643169103078
• UDI-Public: 00643169103078
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/03/2017

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: K13A
• Device Lot Number: 0008020596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided; 03/03/2017
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 03/06/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1