MAUDE Adverse Event Report: MEDTRONIC MEXICO 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	09/24/2019
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, after balloon inflation, when the surgeon tried to deflate it, it could not be deflated even when the handle of the inflation syringe was pulled.The balloon could still not be deflated when the surgeon removed the inflation syringe from the inflatable bone tamp (ibt).Then the locking syringe was attached to the ibt and locking syringe was used instead to suck the contrast media, but the balloon did not deflate.So, the balloon was removed by force.It is said that the balloon among the returned items was in a half inflated state.The procedure was however completed successfully with the same product; and no patient complications were reported due to this event.In the sales rep opinion, probably the product was used without the stylet.
Additional Manufacturer Narrative
Product analysis: visual and functional inspection confirmed the ibt balloon was deformed and three syringe had dried contrast in the tube.Functional inspection confirmed the syringe would not pass any liquid due to the dried contrast in the lines and the balloon would inflate but very slowly.The shape of the inflated balloon was abnormal.It was unable to determine root cause of the non-conformance.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: 9226700
• Report Number: 9612164-2019-04480
• Device Sequence Number: 2360543
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 10/23/2019
• 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