BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTO SCR 1.5X5MM 1.5 SYS 2PK

    MDR report key: 12540216 · Received September 28, 2021

    Report

    Report Number
    0001032347-2021-00463
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Report Date
    March 24, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    0841036055196
    PMA / PMN Number
    K002083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D9, G3, G6, H2, H3, H4, H6, H10. A VISUAL INSPECTION WAS CONDUCTED ON THE PACKAGE. A SINGLE HAIR CAN BE SEEN INSIDE OF THE NON STERILE PACKAGING. THIS COMPLAINT IS CONFIRMED. PER THE PACKAGING SPECIFICATIONS NO HAIR IS ALLOWED INSIDE OF THE PACKAGING. HOWEVER, THERE IS NO RISK TO THE PATIENT AS THE HAIR IS NOT WITHIN THE INNER STERILE BARRIER. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. FOR THE RETURNED PRODUCT THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO MANUFACTURING DEFICIENCY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FLAT TITANIUM PECTUS BAR 11" CAT# JP-0110 LOT# 283130. L-PLT LT REG 2.0 LACTOSORB SYS CAT# 915-2102 LOT# 638640. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 282330. BATTERY POWERDRIVER P2 CAT#50-1010 LOT# 282320. BATTERY POWERDRIVER P2 CAT#50-1010 LOT# 476000. BATTERY POWERDRIVER P2 CAT#50-1010 LOT# 579610. CARROLL-GIRARD SCREW HEX-END CAT# SP-2693 LOT# 818880. LACTO SCR 1.5X4MM 1.5 SYS 2PK CAT# 915-2315 LOT# 727800. LACTOSORB1.5MM XSHAPEEXTPLATE CAT# 915-2423 LOT# 832560. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 692220. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 692220. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 003430. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 003380. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 760440. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 657440. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 657440. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 657440. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 760510. BATTERY POWERDRIVER P2 CAT# 50-1010 LOT# 760350. PLATE 4 HOLE WITH GAP 2.0MM CAT# SP-2292 LOT# 480680. STER TRC TF 18.5MM BNT BUR PL CAT# SP-ST-1020B LOT# 147140. STER TRC 2 XD TF 1.5X4.0MM SCR CAT# SP-ST2-6704 LOT# 071120. FOREIGN COUNTRY: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347 - 2021 - 00441, 0001032347 - 2021 - 00442, 0001032347 - 2021 - 00443, 0001032347 - 2021 - 00444, 0001032347 - 2021 - 00445, 0001032347 - 2021 - 00446, 0001032347 - 2021 - 00447, 0001032347 - 2021 - 00448, 0001032347 - 2021 - 00449, 0001032347 - 2021 - 00450, 0001032347 - 2021 - 00451, 0001032347 - 2021 - 00452, 0001032347 - 2021 - 00453, 0001032347 - 2021 - 00454, 0001032347 - 2021 - 00455, 0001032347 - 2021 - 00456, 0001032347 - 2021 - 00457, 0001032347 - 2021 - 00458, 0001032347 - 2021 - 00459, 0001032347 - 2021 - 00460, 0001032347 - 2021 - 00461, AND 0001032347 - 2021 - 00462.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS FOREIGN MATERIAL FOUND WITHIN STERILE PACKAGING DURING INCOMING INSPECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439694 LACTO SCR 1.5X5MM 1.5 SYS 2PK CRANIOFACIAL BONE SCREW, NON-BIOABSORBABLE, STERILE JEY BIOMET MICROFIXATION NI 728470 0841036055196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10