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

Catalog Number	K08A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent kyphoplasty at t9 due to t9 compression fracture.Intra-op, inflatable bone tamp bent upon attempting to insert it into the working cannula.The device came in contact with the patient.After it bent, a second inflatable bone tamp was opened and the procedure was completed successfully with no further issues.
Additional Manufacturer Narrative
Product analysis: the shaft of the ibt is bent near the "y" connection port.There is blood on the balloon.It is not stated if the balloon had been inflated prior to being inserted into the cannula.Once the balloons are used they may not be able to be deflated and reinserted again as these ibts are one-time use.If information is provided in the future, a supplemental report will be issued.
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): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7720075
• Report Number: 1030489-2018-01053
• Device Sequence Number: 1588129
• Product Code: HRX
• UDI-Device Identifier: 00858196001154
• UDI-Public: 00858196001154
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• 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,Followup,Followup
• Report Date (Section B): 10/04/2018

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: K08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/17/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1