MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

Catalog Number	K13A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2019
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
It was reported that the patient underwent balloon kyphoplasty surgery due to primary osteoporosis.Intra-op, the balloon did not deflate even though the handle was pulled while the trigger of the inflatable bone tamp (ibt ) was being gripped.Since the balloon would deflate when having the handle rotated, the operation was completed without problems as the balloon deflated when the handle was rotated.There was a delay of less than 60 min in overall procedure time as a result of this event.There were no patient symptoms or complications as a result of this event.
Additional Manufacturer Narrative
Product analysis results: visual and functional inspection confirmed the syringe handle is not working properly.The spring has become dislodged which is keeping the handle jammed in place.The handle may have been pulled back with excessive force causing the spring to pop out.Root cause of non-conformance is undetermined.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: 8792470
• Report Number: 9612164-2019-02870
• Device Sequence Number: 1978235
• Product Code: HRX
• UDI-Device Identifier: 00763000025601
• UDI-Public: 00763000025601
• 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): 12/26/2019

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: 11/25/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1