FDA Adverse Event Malfunction Summary report: N

ARTHROSCOPE

MDR report key: 8938895 · Received August 28, 2019

Report

Report Number: 9612164-2019-03607
Event Type: Malfunction
Date Received: August 28, 2019
Date of Event: July 31, 2019
Report Date: December 5, 2019
Manufacturer: MEDTRONIC MEXICO
Product Code: HRX
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: PRODUCT ANALYSIS: VISUAL AND FUNCTIONAL INSPECTION CONFIRMED THE IBT WAS RETURNED WITHOUT THE INNER WIRE SHAFT. FUNCTIONAL INSPECTION WITH A SAMPLE SYRINGE CONFIRMED THE IBT BALLOON WOULD INFLATE AND DEFLATE WITHOUT ANY ISSUES. THE IBT APPEARS TO FUNCTION AS INTENDED. UNABLE TO DETERMINE ROOT CAUSE OF MISSING INNER SHAFT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # KE152, 510K # K123771 AND UDI: (B)(4) IS APPROVED FOR SALE IN US. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY IN L5 VERTEBRAE DUE TO VERTEBRAL FRACTURE. INTRA-OPERATIVELY, THE BALLOON DID NOT INFLATE INSIDE THE VERTEBRAE BUT WORKED WELL OUTSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT. DURING THE SURGERY, SURGEON HAD INSERTED CONTRAST AND THE PRESSURE DISPLAYED WAS HIGHER THAN THE CONTRAST INSERTED. A NEW BALLOON WAS USED FOR THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
734471	ARTHROSCOPE	ARTHROSCOPE	HRX	MEDTRONIC MEXICO	NA	216656429

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR