BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM

    MDR report key: 5365268 · Received January 13, 2016

    Report

    Report Number
    3003506883-2016-10011
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 26, 2015
    Report Date
    December 27, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. PATIENT INITIALS ARE: (B)(6). DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: DATE OF MANUFACTURE: 11/12/2012, EXPIRATION DATE: N/A , A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7082641 OF DHS /DCS LAG SCREW 12.7MM THREAD / 85MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP OR REWORK NOTED. THIS 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 6956080 MET ALL SPECIFICATIONS. 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

    THE DEVICE BECAME DEFORMED INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. PRODUCT INVESTIGATION SUMMARY: THE FOLLOWING COMPLAINT DEVICES WERE RECEIVED FOR EVALUATION: ONE DHS/DCS GUIDE SHAFT WITH FLATS (PART 338.23 / LOT NUMBER UNKNOWN); ONE DHS.DCS LAG SCREW 12.7MM THREAD/85MM (PART 280.850 / LOT NUMBER 7082641); ONE DHS/DCS WRENCH (PART 338.06 / LOT NUMBER 1070); THE RETURNED INSTRUMENTS ARE USED IN THE DHS/DCS DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (TECHNIQUE GUIDE J3045-G). THE COMPLAINT CONDITION FOR THE DHS/DCS LAG SCREW WAS LIKELY CAUSED BY HIGH TORSIONAL LOAD EXPERIENCED BY THE SCREW DURING INSERTION. THESE TORSIONAL LOADS LED TO THE FORCED DEFORMATION OF THE SCREW. THE SCREW COULD NOT RESIST THE APPLIED FORCE, WHICH FINALLY LED TO THE MATERIAL OVERLOAD. THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 205, DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A HIP, A GUIDE SHAFT STRIPPED WHILE INSERTING A LAG SCREW. THE END OF THE LAG SCREW THEN BECAME DEFORMED AND THE DYNAMIC HIP SCREW (DHS) PLATE COULD NOT BE INSERTED OVER IT. A WRENCH WAS USED TO REMOVE IT, BUT WAS THEN STUCK ON THE LAG SCREW. A SECOND SET WAS OPENED TO PUT A NEW LAG SCREW IN AND THE PROCEDURE WAS COMPLETED. THE SAME PLATE WAS USED. THERE WAS A 30 MINUTE DELAY. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THE PATIENT STATUS OUTCOME IS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21527 DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM APPLIANCE,FIXATION,NAIL KTT SYNTHES ELMIRA 7082641

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention