BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L60 SST

    MDR report key: 6890580 · Received September 25, 2017

    Report

    Report Number
    2520274-2017-12332
    Event Type
    Injury
    Date Received
    September 25, 2017
    Report Date
    September 4, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    JDS
    PMA / PMN Number
    K072095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: FAILURE ONE LOCKING SCREW (PART 212.124) BROKE POST-OPERATIVELY AT THE CROSSOVER FROM THE SCREW HEAD TO THE SHAFT. DURING THE INVESTIGATION ONE OTHER LOCKING SCREW (PART 212.106) WAS FOUND TO BE STRONGLY BENT WITH FLATTENED THREAD FLANKS IN BENDING DIRECTION. DIMENSION 212.124: THE RELEVANT DIMENSION OF THE BROKEN SCREW (CORE DIAMETER AT FRACTURE FACE) WAS CHECKED WITH CALIPER 3-01-19789 AND WITH 3.04MM FOUND TO BE IN COMPLIANCE WITH SPECIFICATION 3MM +/-0.1 OF THE TECHNICAL DRAWING. 212.106: THE RELEVANT DIMENSIONS COULD NOT BE CHECKED DUE TO THE DEFORMATION AND THE FLATTENED THREAD FLANKS. MATERIAL THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS OF BOTH DEVICES SHOWED NO DEVIATIONS REGARDING, DIMENSIONS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-1. THE FRACTURE FACE OF THE BROKEN SCREW IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. CONCLUSION NO PRODUCT FAULT COULD BE DETECTED. THE LOT OF THE BROKEN SCREW WAS MANUFACTURED WITH A LOT SIZE OF (B)(4) PIECES IN AUGUST 2016 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER (NEITHER THE UNSTERILE LOT L111604 NOR THE AFTERWARDS STERILIZED LOT L254656). THE LOT OF THE DEFORMED SCREW WAS MANUFACTURED WITH A LOT SIZE OF (B)(4) IN JANUARY 2016 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER (NEITHER THE UNSTERILE LOT 9794155 NOR THE AFTERWARDS STERILIZED LOT 9808285). BASED ON THE PROVIDED INFORMATION WE HAVE TO ASSUME THAT THE MENTIONED FALL DID LEAD TO A MECHANICAL OVERLOAD SITUATION AND FINALLY THE BREAKAGE OF THE SCREW. THAT THE SCREW HEAD OF ANOTHER RECEIVED SCREW IS STRONGLY BENT WITH FLATTENED THREAD FLANKS IN THE BENDING DIRECTION, DOES ALSO SPEAK FOR MECHANICAL OVERLOAD SITUATION BY A FALL. 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

    PATIENT IDENTIFIER AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF IMPLANT REPORTED AS (B)(6) 2017. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. CONCOMITANT DEVICE THERAPY DATE REPORTED AS (B)(6) 2017. INITIAL REPORTER HOSPITAL TELEPHONE: (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. CONCOMITANT DEVICE THERAPY DATE REPORTED AS (B)(6) 2017 BUT EXACT DATE IS UNKNOWN. THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED: MANUFACTURING SITE: (B)6). MANUFACTURING DATE: 23. AUG. 2016. NO NONCONFORMANCES (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. THE EVALUATION HAS SHOWN THAT THIS SCREW WAS MADE OUT OF BLANK 212.124.999 WITH LOT H140491. THE DHR FOR THE BLANK IS AS FOLLOWS: MANUFACTURING LOCATION: MONUMENT. LOT WAS RELEASE TO BP55 DATE: 14-JUL-2016. PART #: 212.124.999, LOT#: H140491 ¿ 3.6MM SCREW BLANK, 60MM 03.5 LOCKING SCREW W/SD15. QUANTITY 960. COMPONENT PARTS REVIEWED: 11139 - RAW MATERIAL LOT BP-80 LOT ¿ H083599. RAW MATERIAL MEET SPECIFICATION. RAW MATERIAL WAS RECEIVED FROM ZAPP USA INC. ZAPP MANUFACTURING AND INSPECTION CERTIFICATE MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR HEADING MET INSPECTION ACCEPTANCE CRITERIA. NO NCRS 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. CORRECTED DATA: 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 (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A PEDIATRIC LOCKING COMPRESSION PLATE (LCP) HIP PLATE AND SCREWS ON UNKNOWN DATE IN (B)(6) 2017. ON UNKNOWN DATE, PATIENT FELL AND SUFFERED AN ABDUCTION OF THE LEG. IT WAS REPORTED AN UNKNOWN LOCKING SCREW WAS BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 AND REVISED TO AN ANGLE BLADE PLATE. THE PEDIATRIC HIP PLATE WAS REPORTED TO BE REMOVED INTACT. REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: PEDIATRIC LCP HIP PLATE 3.5MM 110 DEGREE (02.108.311S, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT REPORTED PART: 1X 02.108.311 / L142388 LCP PAED-HIPPL 3.5 110° W/19 ; 2X 212.106 / 9794155 LOCKSCR Ø3.5 SELF-TAP L20 SST; 1X 212.112 / 3665581 LOCKSCR Ø3.5 SELF-TAP L32 SST; 1X 212.124 / L289963 LOCKSCR Ø3.5 SELF-TAP L60 SST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670620 LOCKSCR Ø3.5 SELF-TAP L60 SST NAIL,FIXATION,BONE JDS SYNTHES GRENCHEN L111604

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention PLATE (02.108.311S, LOT UNKNOWN, QTY 1)