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

Catalog Number	K08A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
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 inflation of the inflatable bone tamp (ibt), the balloon ruptured while the balloon was indwelt in the patient and the cement was being prepared.The balloon ruptured at 80psi.Because the inflation was already finished, a spare ibt was not needed and cement insertion was performed after removing the ibt.No fragment of the ruptured balloon remained inside the patient.The patient was not allergic to the contrast media; and no patient complications were reported.The doctor believes that the rupture might have occurred due to the effects of bone spicule.
Additional Manufacturer Narrative
Product analysis: visual and optical evaluation of the ibt balloon revealed a sharp cut at the balloon, disallowing inflation.The morphology, location and timing of the balloon rupture is consistent with in vivo contact with sharp object, such as bone splinters.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: 9102692
• Report Number: 9612164-2019-04019
• Device Sequence Number: 2383865
• Product Code: HRX
• UDI-Device Identifier: 00763000025588
• UDI-Public: 00763000025588
• 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): 12/05/2019

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: K08A
• Device Lot Number: 0009235473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1