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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE

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MEDTRONIC MEXICO ARTHROSCOPE Back to Search Results
Catalog Number K13A
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2019
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
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.
 
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.
 
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Brand NameARTHROSCOPE
Type of DeviceARTHROSCOPE
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 Key8792470
MDR Text Key151120410
Report Number9612164-2019-02870
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K041454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK13A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
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

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