MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

Catalog Number K13A

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2018

Event Type  malfunction  

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 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.

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
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8172861
• MDR Text Key: 130616914
• Report Number: 9612164-2018-03662
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00613994703989
• UDI-Public: 00613994703989
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1