BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 14MM-STERILE

    MDR report key: 6829723 · Received August 30, 2017

    Report

    Report Number
    3000270450-2017-10313
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    August 3, 2017
    Report Date
    August 3, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED ON THE NON- STERILLE PART. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 31-AUG-2015, PART NO: 04.210.114, LOT NO: 9812092 (NON-STERILE) - 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM. QUANTITY (B)(4). COMPONENTS REVIEWED: RAW MATERIAL PART 21015, BP80, LOT 7688331 MEET SPECIFICATION. RAW MATERIAL RECEIVED FROM MAGNUM MANUFACTURING CENTER, I. RAW MATERIAL REWORK INSPECTION FOR DIAMETER CHECK REQUESTED ON 23-JUL-2014. CERTIFICATE OF COMPLIANCE RECEIVED FROM MARK TWO ENGINEERING, INC. FOR 2.4MM VARIABLE ANGLE SCREW 14MM MEET SPECIFICATION. INSPECTION SHEET FOR INCOMING FINAL INSPECTION MEETS 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 THIS 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.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED. THE REPORT INDICATES THAT: PER COMPLAINT DESCRIPTION, 1X ARTICLE 04.210.114S WITH LOT 9646612 / VA LOCKSCR Ø2.4 SELF-TAP L14 TAN RECEIVED AND FORWARDED FOR MANUFACTURING INVESTIGATION TO MANUFACTURING PLANT: AS RECEIVED CONDITION OF DEVICE: THE ANODIZE COLOR IS STRIPPED AND THE THREADS ARE DAMAGED ON THE HEAD. THERE IS SOME SLIGHT DAMAGE ON SHAFT THREADS. ¿THE LOCKING SCREW WAS NOT LOCKED TO THE PLATE HOLE.¿ THE HEAD PROFILE AND HEAD THREAD PROFILE COULD NOT BE CHECKED DUE TO DAMAGE. SINCE FEATURES RELEVANT TO THE COMPLAINT COULD NOT BE CHECKED THIS COMPLAINT CANNOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENT OCCURRENT INTRAOPERATIVE. DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR STERILE PART# 04.210.114S, LOT# 9646612. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: SEP 16, 2015, EXPIRY DATE: SEP 01, 2029. NON-STERILE PART# 04.210.114, LOT# 9812092. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: AUG 31, 2015. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    AUG 30, 2017 ADDITIONAL UPDATED INFORMATION: IT WAS REPORTED THAT THE VA LOCKING SCREW 2.7MM LOCKED THE PLATE ON THE PLATE SHAFT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT SURGERY FOR THE FIFTH METATARSAL FRACTURE. THE VA (VARIABLE ANGLE) FOOT T-FUSION PLATE WAS USED DURING THE PROCEDURE. DURING THE PROCEDURE, ONE VA LOCKING SCREW 2.4MM WAS USED TO THE DISTAL PART, BUT THE LOCKING SCREW DID NOT LOCK TO THE PLATE HOLE. ANOTHER LOCKING SCREW, SAME IN SIZE, WAS USED DUE TO A POSSIBLE SCREW HEAD ANOMALY. HOWEVER, THE SECOND LOCKING SCREW DID NOT LOCK EITHER, AND THERE WAS A POSSIBLE PLATE HOLE ANOMALY. THE SURGICAL TECHNIQUE WAS FOLLOWED WELL BY THE INSTRUCTIONS (THE DRILL SLEEVE WAS SET TO THE PLATE). THE PLATE IN QUESTION WAS NOT PLANNED TO BE REMOVED. THE VA LOCKING SCREW 2.7MM WAS USED TO THE SHAFT OF THE PLATE. THE SURGERY WAS EXTENDED FOR FIVE (5) MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. CONCOMITANT DEVICE: T-FUSION PL 2.4/2.7 VA LOCK 2HO L35 HE 2 (PART# 04.211.253S, LOT# H307464, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611748 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM-STERILE PLATE, FIXATION, BONE HRS SYNTHES SELZACH 9646612

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR PART# 04.211.253S, LOT# H307464, QUANTITY 1