BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/110MM-STERILE

    MDR report key: 10876855 · Received November 20, 2020

    Report

    Report Number
    8030965-2020-09114
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819868755
    PMA / PMN Number
    K964259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN PLATES: DHS/DCS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN SCREWS: CORTEX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: JDO. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PART: 280.310S, LOT: 6L58249, MANUFACTURING SITE: (B)(4), SUPPLIER:(B)(4), RELEASE TO WAREHOUSE DATE: JAN 14, 2020, EXPIRY DATE:JAN 1, 2030. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY DHR REVIEW IS DONE FOR NON-STERILE PART: PART NUMBER: 280.310, LOT NUMBER: 18P5904, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: OCT 14, 2019. 02-NOV-2020 BY: (B)(4). PART NUMBER: 280.310, LOT NUMBER: 18P5904, PART MANUFACTURE DATE: OCT 4, 2019, MANUFACTURING LOCATION: (B)(4), PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/110MM PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY REVIEW: THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2020 DURING AN UNKNOWN PROCEDURE, THE SURGEON SCREWED A CORTICAL SCREW INTO THE 4TH HOLE OF A DHS PLATE AND THE SCREW SNAPPED AT THE HEAD/POLE JUNCTION. THE SCREW RECESS REMAINED INTACT. THE HEAD OF THE SCREW WAS REMOVED FROM THE PATIENT. THE SURGEON COMMENTED THAT THE FAILURE WAS LIKELY DUE TO EXCESSIVE SHEAR FORCES GENERATED AS A RESULT OF USING THE SCREW TO REDUCE THE PLATE DOWN ONTO THE BONE RATHER THAN A VERBRUGER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/110MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342363 DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/110MM-STERILE APPLIANCE,FIXATION,NAIL KTT SYNTHES GMBH 6L58249 07611819868755

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR CORTSCR Ø4.5 SELF-TAP L36 SST| CORTSCR Ø4.5 SELF-TAP L36 SST| UNK - PLATES: DHS/DCS| UNK - PLATES: DHS/DCS| UNK - SCREWS: CORTEX| CORTSCR Ø4.5 SELF-TAP L36 SST| UNK - PLATES: DHS/DCS