BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR 5 SELF-TAP L40 SST

    MDR report key: 11108383 · Received January 4, 2021

    Report

    Report Number
    8030965-2021-00003
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    January 1, 2020
    Report Date
    November 6, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819281820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY EVENT YEAR IS KNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PART: 213.340S. LOT: 67P2428. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: SEPTEMBER 2, 2020. EXPIRE DATE: AUGUST 1, 2030. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 213.340S LOT: 67P2428 AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SCREW HEAD IS BROKEN OFF, THE BREAKAGE OCCURRED JUST BELOW THE SCREW HEAD AT THE TRANSITION TO THE SCREW SHAFT. THE BROKEN OFF SHAFT WAS ALSO RETURNED FOR EVALUATION AND THE SCREW HEAD IS STILL JAMMED IN THE PLATE HOLE. THE HEXAGONAL SCREW RECESS SHOWS SIGNS OF USE. THE FRACTURE FACE IS HOMOGENEOUS WHAT INDICATES MATERIAL CONFORMITY. DIMENSIONAL INSPECTION: DIMENSION WAS CHECKED WITH CALIPER 3-01-20766. SCREW SHAFT DIAMETER: MEASURED 5.01MM (SPEC. 5.0MM +0.05/-0.2MM), RESULT = PASS FURTHER DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DAMAGE INCURRED. DOCUMENT/SPECIFICATION REVIEW: PRODUCT DRAWING LOCKING SCREW WAS REVIEWED DURING THIS INVESTIGATION. THE MANUFACTURING RECORD EVALUATION SHOWED THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS SCREW IS MADE OF STAINLESS STEEL PER ISO 5832-1. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE LOCKING SCREW WAS FOUND BROKEN. THE FOR THE COMPLAINT RELEVANT DIMENSION WAS CHECKED AS FAR AS POSSIBLE AND FOUND TO BE WITHIN SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. THE VISUAL INSPECTION SHOWED THAT THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY. A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED, AND WE CONCLUDE THAT THE CAUSE OF THE CRACK IS RELATED TO THE PATIENT¿S FALL. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. (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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT FELL WHILE TRYING TO STAND UP ON HIS OWN WHICH CAUSED A DIFFUSE PAIN AND HAEMATOMA. IT WAS DISCOVERED THROUGH X-RAY THAT THIS CAUSED A FRACTURE OF THE DISTAL THIRD OF THE RIGHT FEMORAL DIAPHYSIS WITH A THIRD FRAGMENT. CORRECTIVE SURGERY TO IMPLANT A NEW PLATE WAS PERFORMED ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS PROVIDED. CONCOMITANT DEVICES REPORTED: LCP-DF 4.5/5 R 11HO L276 SST (PART NUMBER 222.256S, LOT 6L68934, QUANTITY 1). CORTSCR Ø4.5 SELF-TAP L30 SST (PART NUMBER 214.830S, LOT 6L97943, QUANTITY 1). CORTSCR Ø4.5 SELF-TAP L34 SST (PART NUMBER 214.834S, LOT L867775, QUANTITY 1). LOCKSCR Ø5 SELF-TAP L38 SST (PART NUMBER 213.338S, LOT 54P5490, QUANTITY 1). LOCKSCR Ø5 SELF-TAP L60 SST (PART NUMBER 213.360S, LOT 64P8962, QUANTITY 1). LOCKSCR Ø5 SELF-TAP L65 SST (PART NUMBER 213.365S, LOT 64P1186, QUANTITY 1). LOCKSCR Ø5 SELF-TAP L70 SST (PART NUMBER 213.370S, LOT 57P3309, QUANTITY 1). THIS REPORT INVOLVES ONE (1) LOCKSCR Ø5 SELF-TAP L40 SST. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5176 LOCKSCR 5 SELF-TAP L40 SST APPLIANCE,FIXATION,NAIL KTT SYNTHES GMBH 67P2428 07611819281820

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORTSCR Ø4.5 SELF-TAP L30 SST.| CORTSCR Ø4.5 SELF-TAP L34 SST.| LCP-DF 4.5/5 R 11HO L276 SST.| LOCKSCR Ø5 SELF-TAP L38 SST.| LOCKSCR Ø5 SELF-TAP L60 SST.| LOCKSCR Ø5 SELF-TAP L65 SST.| LOCKSCR Ø5 SELF-TAP L70 SST.| UNK - SCREWS: TRAUMA.