BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI LOCKING SCR SLF-TPNG 2.7MM TI LOCKING SCR SLF-TPNG

    MDR report key: 5237952 · Received November 19, 2015

    Report

    Report Number
    2520274-2015-17416
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Report Date
    November 4, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK113364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT ID, DOB & WEIGHT NOT PROVIDER BY REPORTER. UNKNOWN WHEN DEVICE BROKE OR MALFUNCTIONED. ADDITIONAL PRODUCT CODE: HWC. ADDITIONAL LOT NUMBER, UNKNOWN WHICH ONE BELONGS TO DEVICE. DEVICE HISTORY RECORDS WAS ATTEMPTED. THE REPORT INDICATES THAT THE: DHR REVIEW COULD NOT BE CONDUCTED. IT IS UNCLEAR IF THIS SCREW WAS MANUFACTURED IN THE U.S. WITH LOT 9022198 OR MANUFACTURED BY PLANT (B)(4) WITH LOT 8939806. DHR REVIEW WAS NOT POSSIBLE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    NO INFORMATION WAS PROVIDED TO SUGGEST THAT THE HARDWARE REMOVAL PROCEDURE WAS DUE TO AN ADVERSE EVENT. THE BROKEN SCREW WAS DISCOVERED DURING THE SURGICAL PROCEDURE. AS SUCH, ONLY A PRODUCT PROBLEM IS BEING REPORTED FOR THIS COMPLAINT. THE EXACT LOT NUMBER OF THE BROKEN SCREW IS UNKNOWN. HOWEVER, THE LOT IS EITHER 9022198 OR 8939806. DUE TO THE SMALL SIZE OF THE ETCHING ON THE SCREW, THE EXACT LOT IS UNKNOWN. (OTHER): TWO POSSIBLE LOT NUMBERS WERE PROVIDED FOR THIS BROKEN SCREW. POTENTIAL UDI¿S ARE AS FOLLOWS: (B)(4). PART RECEIVED ON DECEMBER 4, 2015 PRODUCT INVESTIGATION SUMMARY: THE HEAD OF THE RECEIVED LOCKING SCREW IS BROKEN OFF AT THE SHAFT END. THE LOCKING THREAD IS WORN, BUT NOT DAMAGED. THE RECESS IS WORN FROM USE, BUT ALSO NOT DAMAGED. THE FRACTURE SURFACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THE BROKEN OFF SCREW SHAFT IS DAMAGED AT THE BROKEN END BECAUSE OF THE REMOVAL ACTIVITIES. THE REMAINING THREAD IS WORN AND THE ANODIZED COLOR HAS PARTIALLY DISAPPEARED DURING USE. BECAUSE OF THE EXISTING DAMAGE AND WEAR, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. A MANUFACTURING CONCLUSION, THEREFORE, CANNOT BE PRESENTED BECAUSE OF THE PRODUCT¿S CONDITION. DUE TO THE SMALL HEAD SIZES OF THESE TYPES OF SCREWS, THE LOT NUMBERS CANNOT BE ETCHED. ACCORDING TO THE COMPLAINT DESCRIPTION, THE EXACT LOT NUMBER IS UNKNOWN, BUT POTENTIALLY 9022198 OR 8939806. THE REVIEW OF THE MANUFACTURING DOCUMENTS OF BOTH LOTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCTS IN QUESTION THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. TWO POTENTIAL LOT NUMBERS FOR THE COMPLAINANT PART WERE IDENTIFIED WITH MANUFACTURING DATES AS FOLLOWS: LOT 9022198 ¿ MANUFACTURED ON JUNE 20, 2014. LOT 8939806 ¿ MANUFACTURED ON APRIL 23, 2014 DEVICE HISTORY RECORD REVIEWS WERE CONDUCTED ON THE TWO POTENTIAL LOT NUMBERS AND THEIR CORRESPONDING NON-STERILE COUNTERPARTS WITH RESULTS AS FOLLOWS: - STERILE LOT 9022198 - MANUFACTURING LOCATION: (B)(4)- MANUFACTURING DATE: JUNE 20, 2014 - EXPIRY DATE: JUNE 1, 2024. NON-STERILE LOT 9005488 - MANUFACTURING LOCATION: (B)(4)¿ MANUFACTURING DATE: JUNE 3, 2014 NO NON-CONFORMANCE REPORTS (NCR) WERE GENERATED DURING PRODUCTION FOR EITHER THE STERILE OR NON-STERILE LOT. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. - STERILE LOT 8939806 - MANUFACTURING LOCATION: (B)(4)- MANUFACTURING DATE: APRIL 23, 2014 - EXPIRY DATE: APRIL 1, 2024 NON-STERILE LOT 8908472 - MANUFACTURING LOCATION: (B)(4)- MANUFACTURING DATE: MARCH 28, 2014 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A BROKEN SCREW WAS FOUND ON A REMOVAL SURGERY ON (B)(6) 2015. THE DETAILS ARE AS FOLLOWS: SURGERY FOR DISTAL CLAVICLE FRACTURE WAS CONDUCTED ON (B)(6) 2014. A CLAVICLE PLATE WITH LATERAL EXTENSION (5 HOLES) WAS USED FOR THE INJURED PART ON THE SURGICAL OPERATION. ONE LOCKING SCREW AND THREE LOCKING SCREWS WERE INSERTED TO THE CLAVICLE PLATE DURING THE SURGERY. THE SURGERY FOR REMOVAL OF THE IMPLANTS WAS HELD ON (B)(6) 2015. THEN, A BROKEN SCREW (ONE OF THE REPORTED SCREWS WITH LENGTH 16 MM) WAS FOUND AT SECOND DISTAL HOLE OF THE CLAVICLE PLATE DURING THE SURGERY. HOWEVER, THE SURGEON SUCCESSFULLY REMOVED THE SCREWS INCLUDING BROKEN ONE AND COMPLETED THE SURGERY. NO SURGICAL DELAY WAS REPORTED. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766737 2.7MM TI LOCKING SCR SLF-TPNG 2.7MM TI LOCKING SCR SLF-TPNG PLATE,FIXATION,BONE HRS SYNTHES SELZACH 9022198

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR