BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST SCR SD XD LK 2.4X10MM

    MDR report key: 21048990 · Received December 31, 2024

    Report

    Report Number
    0001032347-2024-00417
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    July 10, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036281625
    PMA / PMN Number
    K151173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS ITEM# 76-2602ST, LOT#180669; ST PRE-BENT PLATE 12-HOLE. QTY OF 4 SCREWS FROM UNKNOWN COMBINATION OF PART AND LOT BELOW: ITEM 76-2412ST, LOT #155902; 6PK SCREW, SELF DRILL, X-DRV, LOCKING, 6-PK. ITEM 76-2410ST, LOT #230590; 6PK SCREW, SELF DRILL, X-DRV, LOCKING, 6-PK. G2: FOREIGN SOURCE: UNITED KINGDOM CONSUMER: PATIENT. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: CT REPORT DETERMINED NON-UNION OF LEFT LATERAL 8TH RIB FRACTURE. LATER RECORD INDICATED, PATIENT REFRACTURED AT THE SAME SITE OF NON-UNION AND WAS FIXED WITH PLATE AND 4 SCREWS ON EACH SIDE WITH NO INTRA-OPERATIVE COMPLICATIONS/EVENTS. IT WAS REPORTED THE PATIENT ROLLED OVER IN BED AND THE PLATE SUDDENLY SNAPPED, CAUSING EXCRUCIATING PAIN. X-RAYS SHOWED THE PLATE HAD FRACTURED WITH SCREWS PULLED OUT ON A SINGLE SIDE OF THE PLATE. DEVICES EXPLANTED, WITH NO COMPLICATIONS. PLATE WAS FRACTURED IN THE MIDDLE THROUGH THE SCREW HOLE. THE RIB WAS DETERMINED TO BE HEALED, SO THE DECISION WAS MADE TO NOT IMPLANT A NEW PLATE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL 8TH RIB FIXATION DUE TO PAIN AND MALUNION OF A FRACTURE THAT OCCURRED 3 YEARS PRIOR AFTER SNEEZING. SUBSEQUENTLY, APPROXIMATELY FOUR MONTHS POST OP, ROLLED OVER IN BED AND EXPERIENCED SUDDEN PAIN AND RADIOGRAPHIC IMAGING DISPLAYED THAT SCREWS PULLED OUT ON ONE SIDE OF THE PLATE AND THE PLATE HAD FRACTURED. ON A LATER DATE, THE PATIENT UNDERWENT A SECOND OPERATION WHERE THE PLATE AS FOUND BROKE IN THE MIDDLE THROUGH THE SCREW HOLD. ALL PRODUCTS WERE REMOVED AS THE FRACTURE WAS FOUND HEALED AND STABLE AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089216 ST SCR SD XD LK 2.4X10MM PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 230590 00841036281625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11