MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC; ARTHROSCOPE

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
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-op diagnosis: primary osteoporosis type of fracture: compression fracture levels implanted: t12 it was reported that on (b)(6) 2018, intra-op, when performing the installation with adjusting the position of the left balloon before inflation, the tip of the balloon was stuck in the bone and could not be moved.Once the balloon was expanded and attempted to be removed, it did not move.The balloon was expanded with the right balloon at the same time, and was tried to be removed again.It could not be removed.The operation for removing it was repeated several times but it could not be removed.It could not be removed even removing the inner needle and performing the operation which could be assumed.The inner needle was removed, and the balloon could move by being twisted and turned back, but it could not be removed.According to the judgment of the physician, it would be removed with the preparation of the balloon ruptured.After deflating the balloon, it was twisted and the twisted part was blocked.Removing was performed in this state.The tube was cut halfway.The part which was cut was removed again with using kocher, but it could not be removed successfully.The needle external cylinder was inserted through the torn tube and removed.The tip of torn balloon was removed together with the external cylinder.It was removed successfully.It was considered that the tip part of balloon was chipped.There was a possibility that a slight amount of contrast media leaked.No patient complications were reported as a result of this event.According to the report, the balloon could not be removed.The physician also thought that there was a possibility that the balloon was stuck in the bone.A new one was opened to deal with it.
Additional Manufacturer Narrative
Product analysis result: visual functional visual and functional inspection revealed the tip of the ibt has been damaged.About 4 inches of the plastic/rubber sleeve has been separated from the inner metal wire.The ibt will no longer function.No testing can be done since the balloon is no longer attached.Root cause undetermined.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7522559
• Report Number: 1030489-2018-00720
• Device Sequence Number: 1439149
• Product Code: HRX
• UDI-Device Identifier: 00613994703996
• UDI-Public: 00613994703996
• 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,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 07/16/2018; 08/08/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 08/01/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other