XPS® BLADE

Report

• Report Number: 1045254-2017-00398
• Event Type: Malfunction
• Date Received: November 3, 2017
• Date of Event: October 6, 2017
• Report Date: November 30, 2017
• Manufacturer: MEDTRONIC XOMED INC.
• Product Code: EQJ
• PMA / PMN Number: EXEMPT
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: JA
• Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT ANALYSIS INDICATES THREE OPENED SAMPLES OF PART NUMBER 1884005HRE. THE LOT NUMBERS ARE UNKNOWN. THE THREE SAMPLES RETURNED WERE RECEIVED AND IDENTIFIED AS SAMPLES A, B, AND C RESPECTIVELY. THE IDENTIFICATION WAS USED THROUGH THE ANALYSIS PROCESS. A MICROSCOPE AND CALIPERS WERE USED TO EVALUATE THE SAMPLES. SAMPLE A: VISUALLY, THE TIP OF THE INNER CUTTER FRACTURED WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIPS DID NOT BECOME FULLY DETACHED. THE FRACTURE CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER BLADE TEETH. THERE WAS UNEVEN WEAR AT THE TIP NEAR THE FRACTURE POINT. THE DEFORMATION OF THE TEETH IS CONSISTENT WITH THE INNER TIP CONTACTING THE OUTER TIP DURING USE WHILE MOVING IN A COUNTERCLOCKWISE DIRECTION. FOR THIS BREAK TO OCCUR, THE TIP(S) CONFIGURATION WOULD HAVE HAD TO BE OR BECOME DEFORMED. THERE WERE NO SIGNS OF EXCESS PRESSURE BEING APPLIED DURING USE OR IMPROPER LOADING OF THE BLADES INTO THE HANDPIECE. SAMPLE B: VISUALLY, THE INNER TIP BROKE OFF AT THE FIRST PROXIMAL VALLEY WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PORTION THAT BROKE OFF MEASURED 0.22¿. THE BREAK CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER BLADE TEETH. THERE WAS UNEVEN WEAR AT THE TIP NEAR THE BREAK POINT. THE DEFORMATION OF THE TEETH IS CONSISTENT WITH THE INNER TIP CONTACTING THE OUTER TIP DURING USE WHILE MOVING IN A COUNTERCLOCKWISE DIRECTION. FOR THIS BREAK TO OCCUR, THE TIP(S) CONFIGURATION WOULD HAVE HAD TO BE OR BECOME DEFORMED. THERE WERE NO SIGNS OF EXCESS PRESSURE BEING APPLIED DURING USE OR IMPROPER LOADING OF THE BLADES INTO THE HANDPIECE. SAMPLE C: VISUALLY, THE INNER TIP BROKE OFF AT THE FIRST PROXIMAL VALLEY WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PORTION THAT BROKE OFF MEASURED 0.21¿. THE BREAK CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER BLADE TEETH. THERE WAS UNEVEN WEAR AT THE TIP NEAR THE BREAK POINT. THE DEFORMATION OF THE TEETH IS CONSISTENT WITH THE INNER TIP CONTACTING THE OUTER TIP DURING USE WHILE MOVING IN A CLOCKWISE DIRECTION. FOR THIS BREAK TO OCCUR, THE TIP(S) CONFIGURATION WOULD HAVE HAD TO BE OR BECOME DEFORMED. THERE WERE NO SIGNS OF EXCESS PRESSURE BEING APPLIED DURING USE OR IMPROPER LOADING OF THE BLADES INTO THE HANDPIECE. THE DEVICE CONDITIONS WERE OUT OF SPECIFICATION AS IT RELATES TO THE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

THE BLADE HAS BEEN RETURNED FOR ANALYSIS. RESULTS ARE PENDING COMPLETION OF EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

CLARIFICATION FROM THE CUSTOMER INDICATES THAT THERE WAS A TOTAL OF THREE BLADES THAT BROKE AT THE TIP. FRAGMENTS WERE RETRIEVED WITH TWEEZERS AND FORCEPS.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE BLADE TIP BROKE OFF DURING AN ENDOSCOPIC SINUS SURGERY. THERE WAS NO PATIENT INJURY AND NO DELAY TO THE SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
779312	XPS® BLADE	BUR, EAR, NOSE AND THROAT	EQJ	MEDTRONIC XOMED INC.	1884005HRE

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Consequences Or Impact To Patient

Product problems · 1

• Material Fragmentation

Source type · 2

• COMPANY REPRESENTATIVE
• FOREIG

Type of report · 2

• Followup
• Initial submission