MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

Catalog Number	KX203
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
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 patient underwent balloon kyphoplasty at t12 due to compression fracture at t 12.Intra-op, the ibt ruptured.When the physician inserted both trocars as planned then inserted biopsy device in both sides, the physician did not drill and inserted the ibt.The physician began inflating ibt rotating between right and left sides during inflation right then left.When right ibt was in low 100 psi range and approx 3 ml it ruptured.The physician removed and flushed right side with saline, then it is continue to inflate left ibt, it ruptured shortly after, doctor stated approx 3-4 ml and low to mid 100 psi range.The physician flushed again with saline, then inserted cement, approx 3.5 to 4 ml per side and completed case.There were no patient complications as a result of alleged event.

• Brand Name: ARTHROSCOPE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8643542
• Report Number: 9612164-2019-01957
• Device Sequence Number: 3236228
• Product Code: HRX
• UDI-Device Identifier: 00763000025731
• UDI-Public: 00763000025731
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• 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
• Report Date (Section B): 05/27/2019

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: KX203
• Device Lot Number: 0009402469
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR