MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
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 percutaneous vertebroplasty surgery due to primary osteoporosis and compression fracture.Intra-op, ibt (inflation bone tamp) was ruptured.When the ibt was inserted into the vertebral body, the marker was not in a straight line, so it was removed.The balloon had ruptured at the time of removal.It was before turning the handle of the inflation syringe.The same issue occurred on both sides.It was checked outside the patient¿s body that the balloon ruptured and the stylet had popped out.In the opinion of sales rep, the bone has been hard and there was an impression that the surgeon had pushed the ibt in.Curette was not used.Therefore, drilling was performed again, and another product was opened and used.There was a delay of less than 60 minutes in overall procedure time as a result of this event.No patient complications were reported.

• 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: 9594629
• Report Number: 9612164-2020-00253
• Device Sequence Number: 14078380
• Product Code: HRX
• UDI-Device Identifier: 00858196001161
• UDI-Public: 00858196001161
• 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
• Report Date (Section B): 01/16/2020

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 62