BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (SHORT)

    MDR report key: 12747343 · Received November 3, 2021

    Report

    Report Number
    0001038806-2021-02105
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Report Date
    May 12, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001038806-2021-02104-1. THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: INVESTIGATION TYPE CODES WERE ADDED: 4109, 4111, 4110 AND 4114. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 67. H10: NARRATIVE/DATA WAS UPDATED. ONE (1) CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG) (IRE200U), ONE (1) CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (SHORT) (IRE100U), ONE (1) OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 10MM (XIITP5410) AND ONE (1) 3I T3® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 3.25 X 10MM (BOSS310) WERE NOT RETURNED FOR INVESTIGATION, THEREFORE, THE REPORTED EVENT IS NON-VERIFIABLE. BASED ON THE EVALUATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED PRODUCT THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS LIKELY WITHIN SPECIFICATION AND LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW COULD NOT BE PERFORMED FOR THE EXTENSION DRIVERS, AS THE LOT NUMBERS ASSOCIATED WITH THE REPORTED PRODUCT ARE NOT AVAILABLE. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE IRE200U AND IRE100U DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. REVIEW COMPLETED UTILIZING KEYWORDS: (DOES NOT ASSEMBLE) MARCH POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DOES NOT ASSEMBLE) OR PRODUCT (XIITP5410, BOSS310, IRE200U, IRE100U). THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DEVICE & EVENT. THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE PRODUCT. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE FAILURE MODES FOR THE REPORTED EVENT ARE CUSTOMER ERROR IN PLACEMENT OF THE IMPLANTS, SEATING PROTOCOL, AND DAMAGE TO THE IMPLANT SURFACE DURING INSERTION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001038806-2021-02104. ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED PATIENT SEX UNKNOWN / NOT PROVIDED WEIGHT UNKNOWN / NOT PROVIDED LOT NUMBER UNKNOWN / NOT PROVIDED CONCOMITANT PRODUCTS: XIITP5410, LOT# 2020111363-THERAPY DATE UNKNOWN, BOSS310, LOT# 2019041775-THERAPY DATE UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CLINICIAN REPORTED THAT WHEN USING THE RATCHET EXTENSIONS WITH IMPLANTS, THE RATCHET EXTENSIONS WOULD SPIN WITHIN THE IMPLANTS. THE IMPLANT WAS REPLACED WITH A STRAUMAN IMPLANT. NO FURTHER IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647967 CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (SHORT) DENTAL PLACEMENT TOOL NDP BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DENTAL IMPLANT-SEE H10 NARRATIVE| DENTAL IMPLANT-SEE H10 NARRATIVE