MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

Catalog Number	K13A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
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 levels implanted: th12 it was reported that intra-op, when inflated the balloon and tried to check the frontal image, both the right and left stylet could not be removed from the inflatable bone tamp (ibt), and the contrast media leaked from left side.The ibt was removed, and when turning the handle to confirm if the balloon inflated, the contrast media spouted out from the hole of the stylet.Since the cavity formed, the ibt was not returned and the cement was injected, and the operation was completed.The one on right side could not be removed.The right side and left side were operated by different physician.The product came in contact with the patient.No health damage in the patient was reported.
Additional Manufacturer Narrative
Additional information: product analysis results: visual functional there were two ibts and syringes returned one set functioned properly.The ibt on the other set was returned bent in several locations and the center stylet missing.The center sheathing of the ibt had been punctured, allowing liquid to come out where the stylet would lock into place.The bending of the ibt shaft likely allowed the stylet to puncture the sheathing.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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8172861
• Report Number: 9612164-2018-03662
• Device Sequence Number: 13998011
• Product Code: HRX
• UDI-Device Identifier: 00613994703989
• UDI-Public: 00613994703989
• 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): 03/06/2019

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: K13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1