BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5118042 · Received October 1, 2015

    Report

    Report Number
    2520274-2015-16380
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS FOR THE FIVE (5) UNKNOWN BROKEN SCREWS. PARTIAL PART NUMBERS HAVE BEEN IDENTIFIED WITH INFORMATION AS FOLLOWS: FOUR (4) HAVE POSSIBLE PART NUMBER: 02.211.0XX -- 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS ¿ HRS/HWC ¿ K103243. ONE (1) HAS POSSIBLE PART NUMBER: 02.118.5XX ¿ 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS ¿ HRS/HWC ¿ K120854. FOUR (4) OF THE FIVE (5) BROKEN SCREWS WERE RECEIVED ALONG WITH UNIDENTIFIED FRAGMENTS. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A VALID LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION SUMMARY ¿ EACH OF THE FOLLOWING DEVICE(S) WAS RECEIVED BROKEN: HOLLOW REAMER TUBE (PART # 309.280 / LOT # 2028). HOLLOW REAMER TUBE (PART # 309.280 / LOT # 2029). 2.7MM VA LOCKING SCREW (PART# 02.211.0XX / LOT# UNKNOWN) - QTY: 3. 2.7MM METAPHYSEAL SCREW (PART# 02.118.5XX / LOT# UNKNOWN) - QTY: 1. ONE OF EACH OF THE FOLLOWING DEVICE(S) WAS RECEIVED UNDAMAGED: 3.5MM CORTEX SCREW (PART# 204.826 / LOT# UNKNOWN). 3.5MM LOCKING SCREW (PART# 212.107 / LOT# UNKNOWN). 2.7MM VA LOCKING SCREW (PART# 02.211.014 / LOT# UNKNOWN). THE DAMAGED SCREWS SHOW SIGNS OF BEING IMPLANTED. THE SCREW RECESSES (ON THE BROKEN SCREWS) ARE DAMAGED, MOST LIKELY FROM THE REMOVAL TOOLS AND INSTRUMENTATION. THERE ARE NUMEROUS SCREW FRAGMENTS THAT WERE ALSO RETURNED. DUE TO THE SIZE OF THE FRAGMENTS, THE EXACT PART NUMBERS FOR THE BROKEN SCREWS COULD NOT BE DETERMINED. BOTH HOLLOW REAMER TUBES HAVE TEETH BROKEN OFF THAT WERE NOT RETURNED SINCE THE FRAGMENTS WERE DISCARDED. PER THE COMPLAINT DESCRIPTION, THE SCREWS WERE NOT BROKEN PRIOR TO THE REVISION SURGERY. DURING THE REVISION THE FOUR SCREWS AND HOLLOW REAMER TUBE WERE DAMAGED. THE DAMAGE ON ALL DEVICES IS THE RESULT OF A MECHANICAL OVERLOAD SITUATION. THE CONDITION OF THE SCREW FRAGMENTS INDICATES THAT THE HOLLOW REAMER TUBES MIGHT HAVE COME IN CONTACT WITH THE SCREWS DURING THE REMOVAL PROCESS, THEREBY WEAKENING/DAMAGING BOTH THE INSTRUMENTS AND THE IMPLANTS. THIS COMPLAINT IS CONFIRMED AND IS LIKELY DUE TO A COLLISION BETWEEN THE REAMER TUBES AND SCREWS. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DRAWING(S) FOR THE DEVICE(S) WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROXIMAL ULNA OLECRANON HARDWARE REMOVAL PROCEDURE WAS PERFORMED ON SEPTEMBER 18, 2015. DURING THE PROCEDURE, THE SURGEON REMOVED ONE (1) VARIABLE ANGLE OLECRANON PLATE (REMOVED FULLY INTACT) AND EIGHT (8) SCREWS. FIVE (5) OF THE REMOVED SCREWS WERE BROKEN INTRA-OPERATIVELY BELOW THE HEADS. THE OTHER THREE (3) WERE SUCCESSFULLY REMOVED AND REMAIN FULLY INTACT. DURING THE PROCEDURE, TWO (2) HOLLOW REAMERS ALSO BROKE AS THEY WERE USED FOR REAMING OVER THE SCREWS. A SURGICAL DELAY OF APPROXIMATELY SIXTY (60) TO NINETY (90) MINUTES WAS REPORTED. THERE WAS ALSO SIGNIFICANT BONE LOSS RELATED TO REAMING OR "CORING OVER�F THE SCREWS DURING REMOVAL. THE PROCEDURE WAS THEN COMPLETED WITHOUT FURTHER INCIDENT. THIS REPORT PERTAINS TO THE INTRAOPERATIVE EVENTS THAT OCCURRED ON (B)(6) 2015. THE REVISION PROCEDURE AND REASONS LEADING UP TO IT ARE COVERED UNDER A SEPARATE COMPLAINT ((B)(4)). THIS REPORT IS FOR THE FIVE (5) UNKNOWN BROKEN SCREWS. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE FRAGMENTS FROM THE BROKEN REAMER TUBES WERE RETRIEVED AND DISCARDED. UPON RECEIVING THE DEVICES: IT APPEARS THAT ONLY 4 BROKEN SCREW HEADS/TIPS (3 X 02.211.0XX AND 1 X 02.118.5XX) RETURNED WHICH DOES NOT MATCH THE 5 BROKEN SCREWS THAT WERE INITIALLY REPORTED. THERE WERE ALSO SOME FRAGMENTS BUT IT COULD NOT BE CONFIRMED IF THESE WERE PARTS OF THE FIFTH SCREW OR PARTS OF THE OTHER BROKEN SCREWS. THEREFORE, QUANTITY RETURNED FOR UNKNOWN SCREW WILL BE FOUR (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652082 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention