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

Catalog Number	K09A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned with the ibt still inside the cannula.The syringe was connected to the ibt slightly inflated then a (b)(6) pressure was drawn on the balloon.The balloon would not deflate.Several attempts were made to clear anything that may be stuck in the shaft of the ibt, these attempts failed.It was noted that there are several bend lines on the shaft of the balloon where it appears the ibt shaft was bent against the cannula.This has caused the shaft to become deformed and appears to be closing off the shaft when a negative pressure is drawn, creating an area of restriction that is not allowing the balloon to deflate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis for this procedure : primary osteoporosis type of fracture:compression fracture it was reported that intra-op, the balloon could not be deflated.It could be inflated, but could not be deflated easily.The product came in contact with the patient.No patient complications were reported.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7924222
• Report Number: 1030489-2018-01317
• Device Sequence Number: 16596109
• Product Code: HRX
• UDI-Device Identifier: 00613994703996
• UDI-Public: 00613994703996
• 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
• Report Date (Section B): 10/01/2018

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 Expiration Date: 03/22/2020
• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR