MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L DE C.V. ARTHROSCOPE

Catalog Number	K15A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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
It was reported that the patient underwent balloon kyphoplasty at l1 due to vertebral compression fracture (vcf).Intra-op, upon inflation the ibt ruptured at 150 psi.There were no patient symptoms or complications as a result of this event.
Additional Manufacturer Narrative
Additional information: product analysis results: visual functional visual inspection confirmed the ibt was returned.Functional inspection with a sample syringe confirmed the ibt was leaking at the tip of the balloon.Optical examination confirmed there was a cut/hole at the tip.It appears the balloon came in contact with a bone splinter causing the rupture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARTHROSCOPE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L DE C.V.; avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8630610
• Report Number: 9612164-2019-01872
• Device Sequence Number: 19421576
• Product Code: HRX
• UDI-Device Identifier: 00763000025618
• UDI-Public: 00763000025618
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 05/29/2019

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: K15A
• Device Lot Number: WI569652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1