BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-16MM

    MDR report key: 6107692 · Received November 16, 2016

    Report

    Report Number
    2520274-2016-15412
    Event Type
    Injury
    Date Received
    November 16, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K113364
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. (B)(4). (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PART 402.216S LOT UNKNOWN IS BROKEN APART BETWEEN SHAFT AND SCREW HEAD. THE BROKEN SCREW HEAD IS STUCK IN THE PLATE. THE LOT NUMBER IS UNKNOWN SO NO DEVICE HISTORY RECORD COULD BE CONDUCTED. A MICROSCOPIC INVESTIGATION OF THE BROKEN SCREW SHOWS THAT THE SCREW IS BROKEN AT THE TRANSITION FROM THE SCREW HEAD TO THE SCREW SHAFT. THE BROKEN SURFACES ARE HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY. NO IRREGULARITIES CAN BE IDENTIFIED. VISIBLE SIGNS INDICATE HEAVY MECHANICAL LOADINGS DURING INSERTION. IT APPEARS THE MECHANICAL FORCE WAS APPLIED DURING INSERTION WAS EXCEEDED. DUE TO THE TYPE OF DAMAGES AND DEFORMATION IT IS NOT POSSIBLE TO MEASURE ALL RELEVANT DIMENSIONS. THE OUTER DIAMETER ONLY COULD BE MEASURED. ACCORDING TO DRAWING SE_025021 REV. A, THE DIAMETER IS SPECIFIED 2.7MM 0/-0.1 MM, WAS MEASURED WITH MEASURING DEVICE 3-01-19789 AS 2.67MM WHAT IS WITHIN SPECIFICATION. THEREFORE WE CAN EXCLUDE MANUFACTURING RELATED ISSUE. WE ARE NOT ABLE IDENTIFY EXACT ROOT CAUSE FOR THE BREAKAGE. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE USED IN SURGERY FOR DISTAL CLAVICLE FRACTURE ON (B)(6) 2016. IN ORDER TO DECIDE THE TIMING OF IMPLANT EXTRACTION, THE SURGEON DID POSTOPERATIVE OBSERVATION. THEN HE FOUND THAT THE MOST DISTAL SCREW HAD BEEN BROKEN. BECAUSE IT WAS NOT AFFECTING BONE HEALING, HE LEFT THE SCREW AS IT WAS UNTIL THE EXTRACTION. THE SURGEON REGULARLY OBSERVED THE PATIENT'S HEALING STATUS TO DECIDE THE EXPLANT DATE. CONCOMITANT MEDICAL PRODUCTS: LOCKING COMPRESSION PLATE (PART 04.112.006S, LOT 9708770, QUANTITY 1); SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 5); SCREWS (PART 412.105S, LOT 9732909, QUANTITY 2); SCREW (PART 412.104S, LOT 9640259, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756667 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-16MM PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1 PART 04.112.006S, LOT 9708770, LCP| 1 PART 412.104S, LOT 9640259, SCREW| 2 PART 412.105S, LOT 9732909, SCREWS| 5 UNKNOWN SCREWS