BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE 1884005 SILVER BULLET 5PK 4MM (QTY 3)

    MDR report key: 5359270 · Received January 11, 2016

    Report

    Report Number
    1045254-2016-00012
    Event Type
    Injury
    Date Received
    January 11, 2016
    Date of Event
    December 16, 2015
    Report Date
    December 17, 2015
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: QTY 1 , BLADE 1884008 RADENOID 5PK 4MM; LOT #: HG07WR2; MANUFACTURED DATE: 2014-07-28; USE BY DATE: 2022-07-28; 510K: EXEMPT. (B)(4). THE PRODUCT ANALYSIS FOUND THAT FOR PRODUCT 1884005, LOT # 0209852822, THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS ON RECEIPT (INDICATING USE). VISUALLY, THE TIP OF THE INNER BLADE WAS BROKE OFF WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIP WAS RETURNED AND MEASURED 0.22¿ LONG. THE BREAK POINT CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER BLADE TOOTH. WHEN VIEWED UNDER MAGNIFICATION THE FRONT HUB WAS DEFORMED IN THE LOCKING AREA WHICH LIKELY INDICATES EXCESS PRESSURE APPLIED DURING USE / MISUSE. INSTRUCTIONS FOR USE WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE AND THAT THE DEVICE IS USED FOR THE RESECTION OF SOFT TISSUE AND BONE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. THE DEFORMATION OF THE BREAK IS CONSISTENT WITH THE INNER TIP CONTACTING THE OUTER TIP DURING USE. FOR THIS BREAK TO OCCUR, THE TIP WOULD HAVE TO BECOME DEFORMED AND / OR COME IN CONTACT WITH AN UNAPPROVED MATERIAL. IT WAS REPORTED THAT THE PRODUCT CHECKED OK BEFORE USE HOWEVER THIS DOES NOT RULE OUT MISUSE / MISHANDLING, OPERATIONAL FACTORS / OPERATIONAL CONTEXT AND SUPPLIER AS POTENTIAL CAUSES. TWO SAMPLES OF THE SAME PRODUCT AND LOT NUMBER (PART # 1884005, LOT # 0209852822) WERE ANALYZED SEPARATELY. FOR THESE 2 SAMPLES, THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. VISUALLY, THE TIP OF THE INNER BLADE WAS BROKE OFF ON BOTH SAMPLES WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. BOTH TIPS WERE RETURNED AND MEASURED 0.21¿ LONG. THE BREAK POINT CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER BLADE TEETH. WHEN VIEWED UNDER MAGNIFICATION THERE WERE STRIATIONS / ABRASIONS ON THE INNER SHAFT 0.56¿ FROM THE DISTAL FACE OF THE INNER HUBS WHICH LIKELY INDICATES EXCESS PRESSURE APPLIED DURING USE / MISUSE. INSTRUCTIONS FOR USE WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE AND THAT THE DEVICE IS USED FOR THE RESECTION OF SOFT TISSUE AND BONE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. THE DEFORMATION OF THE BREAKS IS CONSISTENT WITH THE INNER TIP CONTACTING THE OUTER TIP DURING USE. FOR THE BREAKS TO OCCUR, THE TIPS WOULD HAVE TO BE DEFORMED AND / OR COME IN CONTACT WITH AN UNAPPROVED MATERIAL. IT WAS REPORTED THAT THE PRODUCT CHECKED OK BEFORE USE HOWEVER THIS DOES NOT RULE OUT MISUSE / MISHANDLING, OPERATIONAL FACTORS / OPERATIONAL CONTEXT AND SUPPLIER AS POTENTIAL CAUSES. REGARDING PRODUCT #1884008, ONE SAMPLE WAS RECEIVED. IT SHOWED EVIDENCE OF BIOLOGICAL CONTAMINATES AS WELL. VISUALLY, THE FRONT HUB IS CRACKED DISTAL TO THE LOCKING AREA WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. FOR THE HUB TO FRACTURE IN THIS LOCATION PRESSURE WOULD HAVE HAD TO BEEN APPLIED TO BOTH SIDES OF THE FRACTURE. WHEN VIEWED UNDER MAGNIFICATION THERE WAS EVIDENCE OF IMPROPER LOADING AND EXCESS PRESSURE BEING APPLIED DURING USE INDICATED BY THE DEFORMATION OF THE LOCKING AREA AND INNER HUB CHEVRONS. INSTRUCTIONS FOR USE WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE, AND CONTAIN DETAILED INSTRUCTIONS FOR LOADING. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. WHEN COMPARED TO LABELING, THE OUTER TUBE IS BENT IN THE WRONG DIRECTION IN RELATION TO THE IRRIGATION BARB ON THE FRONT HUB.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS ADDED TO THE CONCOMITANT DEVICE ANALYSIS ON JAN. 14, 2016. BASED ON ANALYSIS AND FOLLOW-UP, THE CONCOMITANT DEVICE PRODUCT NUMBER WAS CORRECTED TO BLADE 1884006 RAD40 5PK SINUS 4MM (RATHER THAN 1884008). THE CORRECT LOT NUMBER IS HG0JRQL. A THIRD SAMPLE OF THE COMPLAINT DEVICE FROM THE SAME LOT (PART #1884005, LOT # 020985282) WAS RECEIVED AND ANALYZED ON JAN. 11, 2016. ACCORDING TO THE PRODUCT ANALYSIS: CONDITION UPON RECEIPT : 1 UN-SEALED SAMPLE, PART NUMBER 1884005, FROM LOT NUMBER 0209852822 RECEIVED; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. VISUALLY, THE TIP OF THE INNER BLADE WAS BROKE OFF WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIP WAS RETURNED AND MEASURED 0.22¿ LONG. THE BREAK POINT CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER BLADE TOOTH. WHEN VIEWED UNDER MAGNIFICATION THE FRONT HUB WAS DEFORMED IN THE LOCKING AREA WHICH LIKELY INDICATES EXCESS PRESSURE APPLIED DURING USE / MISUSE. INSTRUCTIONS FOR USE WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE AND THAT THE DEVICE IS USED FOR THE RESECTION OF SOFT TISSUE AND BONE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. THE DEFORMATION OF THE BREAK IS CONSISTENT WITH THE INNER TIP CONTACTING THE OUTER TIP DURING USE. FOR THIS BREAK TO OCCUR, THE TIP WOULD HAVE TO BECOME DEFORMED AND / OR COME IN CONTACT WITH AN UNAPPROVED MATERIAL. METHOD: ACTUAL DEVICE EVALUATED; VISUAL INSPECTION; MICROSCOPIC INSPECTION; LABELING EVALUATION. RESULTS: STRESS PROBLEM. CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE PATIENT GOT SINUS SURGERY AND THREE TIPS FROM PRODUCT NUMBER 1884005 AND THE PLASTIC JOINTING PART OF 1884008 BROKE DURING SURGERY. THE PRODUCTS WERE OK BEFORE SURGERY. THE PATIENT UNDERWENT CT SCANNING TO ENSURE THAT NO FRAGMENTS OF 1884005 REMAINED IN THE PATIENT'S BODY. THE PRODUCT 1884008 DID NOT COME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16641 BLADE 1884005 SILVER BULLET 5PK 4MM (QTY 3) BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC 1884005 0209852822

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention