BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM-STERILE

    MDR report key: 6578604 · Received May 19, 2017

    Report

    Report Number
    3000270450-2017-10171
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Date of Event
    April 21, 2017
    Report Date
    April 21, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODE: HRS. THREE (3) POSSIBLE LOT NUMBERS REPORTED: L172060, L211070,AND L298959. UDI: (B)(4) EXPIRATION UNKNOWN(10)LOT NUMBER UNKNOWN. DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. HOSPITAL CONTACT TELEPHONE: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. ARTICLE: 04.211.016S / L172060, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 24.OCT.2016 EXPIRY DATE: 01.OCT.2026, NON-STERILE 04.211.016 / H191141 WAS MANUFACTURED IN US. ARTICLE: 04.211.016S / L211070, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 28.NOV.2016 EXPIRY DATE: 01.NOV.2026, NON-STERILE 04.211.016 / H225291 WAS MANUFACTURED IN US. 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. LOT NUMBER L298959 DOES NOT MATCH TO ARTICLE NUMBER 04.211.016S. DHR-REVIEW NOT POSSIBLE. MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 27-SEP-2016 PART #: 04.211.016, LOT#: H191141 (NON-STERILE) - 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVER RECESS 16MM. QTY: 239. INSPECTION SHEET-. MILL SHAFT THREADS, TURN/THREAD HEAD, FLUTE FINAL INSPECTION MEET INSPECTION ACCEPTANCE CRITERIA. COMPONENTS: 04.211.016.999, 2.8MM TI SCREW BLANK 16MM, LOT H178509 REVIEWED AND MEET SPECIFICATION. MANUFACTURING LOCATION: (B)(4),MANUFACTURING DATE: 09-NOV-2016. PART #: 04.211.016, LOT#: H225291 (NON-STERILE) - 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVER RECESS 16MM. QTY: 238. INSPECTION SHEET- MILL SHAFT THREADS, TURN/THREAD HEAD, FLUTE FINAL INSPECTION MEET INSPECTION ACCEPTANCE CRITERIA. COMPONENTS: 04.211.016.999, 2.8MM TI SCREW BLANK 16MM, LOT H223696 REVIEWED AND MEET SPECIFICATION. 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. 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

    IT WAS REPORTED THAT ALTHOUGH THE SURGEON INSERTED A VARIABLE ANGLE (VA) LOCKING SCREW INTO THE SECOND DISTAL HOLE OF A VARIABLE ANGLE-LOCKING CLAVICLE PLATE, THE SCREW WAS INSERTED IN THE WRONG ANGLE FROM THE ORIGINAL DRILL HOLE. WHILE REPEATING REINSERTION SEVERAL TIMES TO CORRECT THE DIRECTION, THE SCREW BECAME STUCK IN THE BONE. THE SURGEON COMMENTED HE COULD NOT LOCK IT BECAUSE THE SCREW WAS AT THE WRONG ANGLE. THE SURGEON ALSO TRIED TO REMOVE THE SCREW BY USING A SHARP HOOK, BUT THE SCREW COULD NOT BE REMOVED. THE SURGERY WAS EXTENDED FOR 15 MINUTES. THE LOCKING SCREW WILL BE EXTRACTED AFTER BONE UNION BY USING RESCUE SET. CONCOMITANT DEVICE REPORTED: 2.7MM/3.5MM VA LCP MEDIAL DISTAL HUMERUS PLATE (04.117.402S, LOT 9868819, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358717 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM-STERILE SCREW,FIXATION,BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR