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

Catalog Number	K09A
Medical Device Problem Codes	Inflation Problem (1310); Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: primary osteoporosis type of fracture: compression fracture it was reported that intra-op, the balloon distorted on inflation.Additionally, the position of the marker deviated; and thus, the product was taken out of the patient's body.On checking, the stylet and inner tube inside the balloon appeared to be deformed.Therefore, the inflatable bone tamp was replaced with another one after using the curette.The bone quality of the patient seemed to be hard; but the procedure was completed successfully with a new product.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Product analysis: visual inspection confirmed the inner tube located inside the ibt balloon of the ibt has been bent/deformed.Functional inspection with a sample syringe confirmed the balloon was able to inflate and deflate but very slowly.The balloon did not have any punctures that could cause a leak.It appears something is restricting the flow.It was unable to determine root cause of damaged ibt.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 MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9176601
• Report Number: 9612164-2019-04304
• Device Sequence Number: 19480827
• Product Code: HRX
• UDI-Device Identifier: 00763000025595
• UDI-Public: 00763000025595
• 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
• Report Date (Section B): 12/23/2019

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: K09A
• Device Lot Number: 216938263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1