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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
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/05/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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 the patient underwent kyphoplasty surgery due to unknown reason.Intra-op, when the pressure of the balloon was raised to 200 psi, the pressure stopped increasing and it was noticed that the balloon was broken (rupture).No patient complications were reported due to this event.
 
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Brand Name
ARTHROSCOPE
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
MDR Report Key9159618
Report Number9612164-2019-04237
Device Sequence Number16751744
Product Code HRX
UDI-Device Identifier00763000025601
UDI-Public00763000025601
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K041454
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/05/2019
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 NumberK13A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/07/2019
Initial Report FDA Received Date10/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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