BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION PUNCH 4.5MM

    MDR report key: 9072969 · Received September 16, 2019

    Report

    Report Number
    9611102-2019-00024
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 13, 2019
    Report Date
    August 13, 2019
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    NBH
    UDI-DI
    04055207006993
    PMA / PMN Number
    K963022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUNCH RETURNED BY THE CUSTOMER WAS EXAMINED BY THE SPECIALIST DEPARTMENT. IN THE VISUAL EXAMINATION, IT WAS DETERMINED THAT THE PUNCH HEAD HAS BROKEN OUT. THE PUNCH SHOWS SIGNS OF WEAR, AND THIS DAMAGE WAS CAUSED BY IMPROPER USE. IT WAS FOUND THAT THE HARDNESS IS WITHIN SPECIFICATION. SPECIFIED RANGE: 495.0 - 529.0 HV5 / 48.0 - 50.0 HRC; ACTUAL VALUE: 49.1 HRC. THE CONCLUSION OF THE INVESTIGATION IS THAT A USER ERROR IS INDICATED. THE PROBLEM WAS CAUSED BY THE USER APPLYING TOO MUCH FORCE (THE BREAK WAS CAUSED BY OVERLOADING). THE USER IS INFORMED IN THE INSTRUCTIONS FOR USE GA-B 209 ABOUT THE CORRECT USE OF THE PUNCHES. EXCESSIVE FORCE APPLICATION MAY RESULT IN BREAKAGE OR DAMAGE TO THE PRODUCT, WHICH MAY AFFECT ITS FUNCTION. FURTHERMORE, THE USER IS ADVISED TO CARRY OUT A VISUAL INSPECTION AND FUNCTIONAL CHECK AFTER EACH PREPARATION AND BEFORE EACH USE. THE USER IS ADVISED THAT NO MISSING PARTS MAY REMAIN IN THE PATIENT. THE INSTRUCTIONS FOR USE GA - B 209 CONTAINS THE FOLLOWING WARNINGS AND NOTES RELEVANT TO THE PROBLEM DESCRIBED BY THE CUSTOMER: 6 USE CAUTION! THE PRODUCTS HAVE ONLY LIMITED STRENGTH! EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIR THE FUNCTION AND THEREFORE ENDANGER THE PATIENT. IMMEDIATELY BEFORE AND AFTER EACH USE, CHECK THE PRODUCTS FOR DAMAGE, LOOSE PARTS AND COMPLETENESS. MAKE SURE THAT NO MISSING PARTS REMAIN IN THE PATIENT. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. 6.1 PREPARATION CHECK ASSEMBLY (SECTION 8.5); PERFORM A VISUAL CHECK (SECTIONS 7 AND 7.1); CARRY OUT A FUNCTION CHECK (SEE SECTION 7.2). 7 CHECKS CAUTION! BE CAREFUL IF PRODUCTS ARE DAMAGED OR INCOMPLETE! INJURIES OF THE PATIENT, USER OR OTHERS ARE POSSIBLE. RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. RETURN DAMAGED PRODUCTS TOGETHER WITH ANY LOOSE PARTS FOR REPAIR. DO NOT ATTEMPT TO DO ANY REPAIRS YOURSELF. 7.1 VISUAL CHECK CARRY OUT THE FOLLOWING CHECKS: CHECK INSTRUMENTS, IN PARTICULAR THEIR DISTAL AREAS, AS WELL AS THE ACCESSORIES FOR DAMAGE, SHARP EDGES, LOOSE OR MISSING PARTS AND ROUGH SURFACES. CHECK THE HINGE AND HINGE PIN AREA WITH PARTICULAR CARE. CHECK FOR SURFACE CHANGES, SUCH AS HAIR CRACKS AT THE HINGE PIN. ANY LETTERING, LABELING OR IDENTIFICATION NECESSARY FOR THE SAFE INTENDED USE AS MUST BE LEGIBLE. MISSING OR ILLEGIBLE LETTERING, LABELING OR IDENTIFICATION WHICH CAN CAUSE WRONG HANDLING AND REPROCESSING MUST BE RESTORED. THE CUTTING SURFACES OF THE JAW SECTIONS MUST BE SHARP. 7.2 FUNCTION CHECK CARRY OUT THE FOLLOWING CHECKS: CHECK THE JOINTS OF THE PRODUCTS. THE JAW SECTIONS MUST OPEN AND CLOSE EASILY. POTENTIAL HAZARDS WERE TAKEN INTO ACCOUNT IN THE RISK ASSESSMENT B1-2 REV. 05 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE AND ASSESSED WITH AN ACCEPTABLE RISK. THIS RATING IS STILL VALID CONSIDERING THE CURRENT CASE. A SEARCH OF THE COMPLAINTS DATABASE WAS CARRIED OUT FROM 01.01.2016 TO 19.08.2019. DURING THIS PERIOD, 39 SUCTION PUNCHES Ø 4.5MM 891400045 WERE SOLD, DURING THE PERIOD UNDER REVIEW THERE WERE NO FURTHER INCIDENTS. A PRODUCT OR BATCH ERROR IS NOT RECOGNIZABLE. THE REPORTED ISSUE DOES NOT DESCRIBE A GENERAL PRODUCT PROBLEM, WHICH REPRESENTS A NON-CONFORMITY, NEGATIVE TREND OR HITHERTO UNKNOWN HAZARDS. SINCE THE COMPLAINT RELATES TO A HANDLING ERROR, A SYSTEMIC PROBLEM IS NOT RECOGNIZABLE AND THE WARNINGS RELEVANT TO THE PROBLEM DESCRIBED BY THE CUSTOMER IN THE INSTRUCTIONS FOR USE GA - B 209 ARE CONSIDERED TO BE SUFFICIENT, NO FURTHER INVESTIGATION OR ACTION BY THE MANUFACTURER IS WARRANTED. THIS CASE IS CONSIDERED CLOSED, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON AUGUST 13, 2019, RICHARD WOLF GMBH (RW GMBH) RECEIVED THE FOLLOWING INFORMATION: DURING AN ARTHROSCOPY OF A KNEE JOINT, A PINHEAD-SIZED PIECE OF THE TIP OF THE PUNCH REMAINED IN THE PATIENT'S JOINT AFTER THE INSERTION OF THE SUCTION BITE PUNCH AND WAS WASHED INTO THE POSTERIOR PARTS OF THE KNEE JOINT BY THE IRRIGATION PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868103 SUCTION PUNCH 4.5MM SUCTION PUNCH Ø 4.5MM NBH RICHARD WOLF GMBH 89140.0045 6131289 04055207006993

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention