BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5209981 · Received November 9, 2015

    Report

    Report Number
    2520274-2015-17118
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 22, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PART 04.211.016S, LOT 9592613: MANUFACTURING DATE: 05AUGUST2015. EXPIRY DATE: 01JULY2025 (NON-STERILE: PART 04.211.016, LOT 9809245: MANUFACTURING DATE: 20MAY2015). PART 04.211.020S, LOT 9257417: MANUFACTURING DATE: 24NOVEMBER2014. EXPIRY DATE: 01NOVEMBER2024 (NON-STERILE: 04.211.020, LOT 7825894: MANUFACTURING DATE: 14OCTOBER2014).PART 04.211.022S, LOT 9328270: MANUFACTURING DATE: 19JANUARY2015. EXPIRY DATE: 01JANUARY2025 (NON-STERILE: 04.211.022, LOT 7804177: MANUFACTURING DATE: 23SEPTEMBER2014). PART 04.211.028S, LOT 8394433: MANUFACTURING DATE: 15MAY2013. EXPIRY DATE: 01APRIL2023 (NON-STERILE: 04.211.028, LOT 7333436: MANUFACTURING DATE: 26MARCH2013). PART 04.211.030S, LOT 9257420: MANUFACTURING DATE: 24NOVEMBER2014. EXPIRY DATE: 01NOVEMBER2024 (NON-STERILE: 04.211.030S, LOT 7798380: MANUFACTURING DATE: 07OCTOBER2014). PART 04.211.042S, LOT 9401650: MANUFACTURING DATE: 12MARCH2015. EXPIRY DATE: 01MARCH2025 (NON-STERILE: 04.211.042, LOT 7878717: MANUFACTURING DATE: 17DECEMBER2014). PART 04.211.050S, LOT 9521630: MANUFACTURING DATE: 12JUNE2015. EXPIRY DATE: 01JUNE2025 (NON-STERILE: 04.211.050, LOT 7889401: MANUFACTURING DATE: 09JANUARY 2015). PART 04.211.056S, LOT 9210039: MANUFACTURING DATE: 21OCTOBER2014. EXPIRY DATE: 01OCTOBER2024 (NON-STERILE: 04.211.056, LOT 7794853: MANUFACTURING DATE: 15SEPTEMBER2014). PART 04.211.060S, LOT 9392521: MANUFACTURING DATE: 05MARCH2015. EXPIRY DATE: 01FEBRUARY2025 (NON-STERILE: 04.211.060, LOT 7898176: MANUFACTURING DATE: 14NOVEMBER2015). A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL POTENTIAL PART/LOT NUMBERS WAS COMPLETED: THE STERILE PART NUMBER WAS REVIEWED BY (B)(4) AND THE NON-STERILE PART NUMBER AT (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. EXACT AGE UNKNOWN; REPORTED AS OVER 80 YEARS OLD DEVICE BROKE DURING INSERTION; NOT CONSIDERED IMPLANTED/EXPLANTED. 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.

    Additional Manufacturer Narrative · 1

    REMOVE VERBAIGE "THIS COMPLAINT IS LINKED TO (B)(4)" 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SYNTHES CANNOT IDENTIFY WHICH OF THE REPORTED DEVICES IS THE COMPLAINED DEVICE. THE PART NUMBERS THAT WERE REPORTED ARE: THE BROKEN (SCREW) IS ONE OF THE FOLLOWING: 04.211.016S LOT. 9592613; 04.211.020S LOT. 9257417; 04.211.022S LOT. 9328270; 04.211.028S LOT. 8394433; 04.211.030S LOT. 9257420; 04.211.042S LOT. 9401650; 04.211.050S LOT. 9521630; 04.211.056S LOT. 9210039; 04.211.060S LOT. 9392521. THIS REPORT IS FOR UNKNOWN SCREW/UNKNOWN LOT NUMBER. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE SURGEON COMMENTED THAT THE PATIENT'S (AGE: OVER 80 YEARS OLD) BONE DENSITY COULD NOT BE THE REASON TO BREAK THE REPORTED SCREW.

    Description of Event or Problem · 1

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SURGERY FOR DISTAL HUMERAL FRACTURE WITH VA DHP (04.117.601S) WAS HELD ON (B)(6) 2015. DURING THE SURGERY, THE REPORTED VA LOCKING SCREW WAS BROKEN AT THE SCREW HEAD BEFORE THE SCREW HEAD REACHING AT THE PLATE. THE SURGEON DECIDED LEAVING THE BROKEN SCREW IN THE PATIENT'S BODY. THE SURGERY WAS COMPLETED WITHOUT REMOVING BROKEN PIECE OF THE SCREW. THE SURGERY WAS EXTENDED FOR 10 MINUTES. NO MATERIAL WILL BE RETURNED TO SWITZERLAND FOR INVESTIGATION. THIS COMPLAINT IS LINKED TO (B)(4). THIS REPORT IS 1 OF 1 FOR (B)(4). THIS COMPLAINT INVOLVES 2 PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740093 SCREW, FIXATION, BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention