BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITCP RESORBABLE INTERFERENCE SCREW

    MDR report key: 12568952 · Received October 4, 2021

    Report

    Report Number
    3004549189-2021-00007
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 15, 2021
    Report Date
    May 3, 2021
    Manufacturer
    S.B.M. SAS
    Product Code
    HWC
    PMA / PMN Number
    K070507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REQUESTED TO COMPLETE OUR INVESTIGATIONS: CORRESPONDING TO PER TRANSMITTED, PRODUCT: 9/35, LOT: 190068 WAS INSIDE THE BOX FOR A PRODUCT BOX 7/25 LOT: 190491 REQUESTED: DO WE AGREE? YES. THE SCREW WAS NOT USED BY THE SURGEON: IS IT RIGHT? YES, NOT IMPLANTED. IF IT'S RIGHT, WHAT WAS USED TO COMPLETE THE PROCEDURE (PART AND LOT INFORMATION)? AN ENDO BUTTON. WHAT WAS THE IMPACT TO PATIENT? NONE BEYOND EXTENDED SURGERY TIME. DOES THE "COMPLEMENTARY SURGERY" STIPULATED IN THE PER CORRESPOND TO THE SURGICAL DELAY OF 45 MINUTES? YES. CAN YOU CHECK HOW MANY BATCH SCREWS 190491 (Ø7L25) ARE STILL AVAILABLE (UNUSED) TO DATE? INQUIRING. HOW MANY BATCH SCREWS TOO FOR LOT: 190068 (Ø9L35)? INQUIRING. IS THIS INCIDENT REPORTED TO THE FDA? UNKNOWN IF DOCTOR SENT INFORMATION. ZIMMER BIOMET DID NOT REPORT TO FDA. BATCH NUMBERS: 190491 AND 190068: USE BEFORE 2022-01-01. WE NOTE THAT THERE WAS NO INJURY / DELAY IN THE SURGERY OVER THAN 30MN / SURGICAL COMPLICATION NOTIFIED ON THE INCIDENT REPORT: "SURGEON HAD TO ALTER HIS INITIAL TREATMENT PLAN". NO PRODUCT RETURNED (NOT USED AND DISCARDED) BUT PHOTOS TRANSMITTED. RESULT OF INVESTIGATION: SCREW Ø9L35, LOT: 190068 INSIDE THE BOX IS WELL IDENTIFIED: ALL OF LABELS ARE CONFORM. WE BELIEVE THAT 6 BOXES LOT: 190068 WERE ISOLATED JUST BEFORE SHIPMENT (VISUAL DEFECT ON THE LABEL OF THE BOX) AT THE SAME TIME AS SOME BOXES OF LOT: 190491 (DELIVERY OF THESE 2 LOTS ON THE SAME DAY). THESE SCREWS WERE ALL RELABELED IN AN EMERGENCY UNDER THE SAME LOT NUMBER: 190491 (VERY RARE INCIDENT / OUT OF PACKAGING PROCESS). WE DELIVERED (B)(4) SCREWS (LOT: 190491) FOR (B)(4) SCREWS MANUFACTURED: THE CAUSE OF THE QUANTITY ERROR HAD NOT BEEN VERIFIED AND DURING THIS PERIOD (FEBRUARY 2019), IT WAS POSSIBLE TO REALIZE A MANUAL ENTRY INTO STOCK (NOT TODAY). SO, COMPUTER BLOCKING DID NOT WORK. WE HAVE INITIATED A VOLUNTARY PRODUCT RECALL FOR BATCH 190491 ONLY AND ARE CONTACTING OUR DISTRIBUTOR ABOUT THIS. 3 MEDICAL DEVICES WERE IDENTIFIED / 6. EXPIRY DATE: 2022-01-01. POTENTIAL RISK TO PATIENT/USERS: DELAY IN SURGERY / IMPACT ON SURGICAL TECHNIQUE BREAKAGE OF THE SCREW IF IT IS FORCED. SBM HAD DETERMINED TO REMOVE THE PRODUCTS FROM THE LOT: 190491 UNUSED FROM THE MARKET. ZIMMER BIOMET HAD CONDUCTED THE FIELD ACTION GLOBALLY AND IDENTIFIED 71 PRODUCT(S). THE DETAILS ARE AS FOLLOWS: 8 PRODUCT(S) HAS/HAVE BEEN RETURNED TO BIOMET GSCC. 59 PRODUCT(S) HAS/HAVE BEEN CONSIDERED DISPOSITIONED AT CUSTOMER LOCATIONS & PHYSICAL UNAVAILABLE. 2 PRODUCT(S) HAS/HAVE BEEN PHYSICAL SCRAPPED UNDER ZIMMER BIOMET CONTROL. 2 PRODUCT(S) HAS/HAVE BEEN LOST. ZIMMER BIOMET IDENTIFIED 43 CUSTOMER(S). THE DETAILS ARE AS FOLLOWS: 41 CUSTOMER(S) HAS/HAVE SIGNED THE FIELD SAFETY NOTICE (FSN). 1 CUSTOMER(S) HAS/HAVE REFUSED TO SIGN THE FIELD SAFETY NOTICE (FSN). 1 CUSTOMER(S) HAS/HAVE BEEN CONSIDERED AS NOT RESPONDING AFTER THREE REMINDERS. THIS FSCA IS CONSIDERED CLOSED PER ZIMMER BIOMET PROCESS AND PER SBM. IN THE END, 60 BOXES WERE RETURNED TO SBM (IN THE CONTEXT OF COMPLAINTS REGISTERED AND RECALL OF THE LOT): THE 6 BOXES CONCERNED WERE IDENTIFIED AND SCRAPPED. CORRECTIVE ACTION: IMPLEMENTATION IN THE QUALITY SYSTEM DOCUMENTATION OF THE REVISED ENR 2018.26 LABELLING SHEET AND UPDATE OF PR 2004.6 "PACKAGING" APPLICABLE TO EXTERNAL AND INTERNAL PACKAGING AND LABELLING, ONLY FOR REPACKAGING AFTER THE LABELLING WORKSHOP (NOVEMBER 2021) TRAINING OF THE PRODUCTION TEAM TO THE PR 2004.6 "CONDITIONING" ON THE SPECIFICATIONS TO BE TAKEN FOR RECONDITIONING (MONTHLY QUALITY MEETING OF OCTOBER 2021). NO FAILURE WAS OBSERVED SINCE 17 DECEMBER 2021 BY SBM.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REQUESTED TO COMPLETE OUR INVESTIGATIONS: CORRESPONDING TO PER TRANSMITTED, PRODUCT 9/35 LOT 190068 WAS INSIDE THE BOX FOR A PRODUCT BOX 7/25 LOT 190491 REQUESTED: DO WE AGREE? YES. THE SCREW WAS NOT USED BY THE SURGEON: IS IT RIGHT? YES, NOT IMPLANTED. IF IT'S RIGHT, WHAT WAS USED TO COMPLETE THE PROCEDURE (PART AND LOT INFORMATION)? AN ENDO BUTTON. WHAT WAS THE IMPACT TO PATIENT? NONE BEYOND EXTENDED SURGERY TIME. DOES THE "COMPLEMENTARY SURGERY" STIPULATED IN THE PER CORRESPOND TO THE SURGICAL DELAY OF 45 MINUTES? YES. CAN YOU CHECK HOW MANY BATCH SCREWS 190491 (Ø7L25) ARE STILL AVAILABLE (UNUSED) TO DATE? INQUIRING. HOW MANY BATCH SCREWS TOO FOR LOT 190068 (Ø9L35)? INQUIRING. IS THIS INCIDENT REPORTED TO THE FDA? UNKNOWN IF DOCTOR SENT INFORMATION. ZIMMER BIOMET DID NOT REPORT TO FDA. BATCH NUMBERS 190491 AND 190068: USE BEFORE 2022-01-01. WE NOTE THAT THERE WAS NO INJURY - DELAY IN THE SURGERY OVER THAN 30MN - SURGICAL COMPLICATION NOTIFIED ON THE INCIDENT REPORT: "SURGEON HAD TO ALTER HIS INITIAL TREATMENT PLAN". NO PRODUCT RETURNED (NOT USED AND DISCARDED) BUT PHOTOS TRANSMITTED. _____________________________________________________________ RESULT OF INVESTIGATION: SCREW Ø9L35 LOT 190068 INSIDE THE BOX IS WELL IDENTIFIED: ALL OF LABELS ARE CONFORM. WE BELIEVE THAT 6 BOXES LOT 190068 WERE ISOLATED JUST BEFORE SHIPMENT (VISUAL DEFECT ON THE LABEL OF THE BOX) AT THE SAME TIME AS SOME BOXES OF LOT 190491 (DELIVERY OF THESE (B)(4) LOTS ON THE SAME DAY). THESE SCREWS WERE ALL RELABELED IN AN EMERGENCY UNDER THE SAME LOT NUMBER 190491 (VERY RARE INCIDENT / OUT OF PACKAGING PROCESS). WE DELIVERED (B)(4) SCREWS (LOT 190491) FOR (B)(4) SCREWS MANUFACTURED: THE CAUSE OF THE QUANTITY ERROR HAD NOT BEEN VERIFIED AND DURING THIS PERIOD (FEBRUARY 2019), IT WAS POSSIBLE TO REALIZE A MANUAL ENTRY INTO STOCK (NOT TODAY). SO, COMPUTER BLOCKING DID NOT WORK. WE HAVE INITIATED A VOLUNTARY PRODUCT RECALL FOR BATCH 190491 ONLY AND ARE CONTACTING OUR DISTRIBUTOR ABOUT THIS. 3 MEDICAL DEVICES WERE IDENTIFIED / 6. EXPIRY DATE: 2022-01-01. POTENTIAL RISK TO PATIENT/USERS: DELAY IN SURGERY - IMPACT ON SURGICAL TECHNIQUE - BREAKAGE OF THE SCREW IF IT IS FORCED.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN US: COMPLAINT DESCRIPTION: "THE DEVICE IS NOT BEING RETURNED. DEVICE WAS USED IN THE SURGICAL FIELD AND THUS DISPOSED. IT WAS REPORTED THAT THE SURGEON REQUESTED A 7/25 COMPOSITE TCP. STARTED TO PUT IT IN, AS THEY WERE, IT STARTED SHEARED OFF THE TENDON REPAIR. AT WHICH TIME IT WAS NOTICED THAT THE STICKERS IN THE BOX AND IMPLANT WERE A 9/35 NOT 7/25 AS LABELED ON THE BOX".

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN US: COMPLAINT DESCRIPTION: "THE DEVICE IS NOT BEING RETURNED. DEVICE WAS USED IN THE SURGICAL FIELD AND THUS DISPOSED. IT WAS REPORTED THAT THE SURGEON REQUESTED A 7/25 COMPOSIT TCP. STARTED TO PUT IT IN, AS THEY WERE, IT STARTED SHEARED OFF THE TENDON REPAIR. AT WHICH TIME IT WAS NOTICED THAT THE STICKERS IN THE BOX AND IMPLANT WERE A 9/35 NOT 7/25 AS LABELED ON THE BOX".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471207 COMPOSITCP RESORBABLE INTERFERENCE SCREW BONE FIXATION SCREW HWC S.B.M. SAS 190491

    Patients

    Seq Age Sex Outcome Treatment
    1 000 YR Unknown Other