BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 2H-STER

    MDR report key: 7208163 · Received January 19, 2018

    Report

    Report Number
    2939274-2018-50348
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 29, 2017
    Report Date
    December 29, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982178671
    PMA / PMN Number
    K033556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: DHR REVIEW WAS COMPLETED. PART NUMBER: 282.610S LOT NUMBER: 6071486 PART MANUFACTURE DATE: 18-FEB-2009 MANUFACTURING LOCATION: (B)(4) PART EXPIRATION DATE: 31-JAN-2018 (B)(4). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 135 DEG LCP DHHS SIDEPLATE-STD BARREL 2H STERILE 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. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED ONE MATERIAL REVIEW RECORD (MRR) TO BE ASSOCIATED TO BP82 RAW MATERIAL LOT 5240128 AND ONE NONCONFORMING REPORT (NCR) TO BE ASSOCIATED TO BP82 RAW MATERIAL LOT 5861879. (B)(4) WAS GENERATED DUE TO THREE ISSUES. THE FIRST ISSUE WAS THE OUTSIDE DIAMETER OF THE MATERIAL MEASURED ABOVE THE UPPER SPECIFICATION LIMIT. THE SECOND ISSUE WAS THE INSIDE DIAMETER MEASURED BELOW THE LOWER SPECIFICATION LIMIT. THE THIRD ISSUE WAS THE LENGTH MEASURED ABOVE THE UPPER SPECIFICATION LIMIT. ALL THE MATERIAL INCLUDED IN THIS LOT WAS DISPOSITIONED TO BE USED AS IS AS THE OUTSIDE DIAMETER OF THE RAW MATERIAL WOULD HAVE BEEN REDUCED DURING NORMAL MANUFACTURING PROCESSES AND BOTH THE LENGTH AND THE INSIDE DIAMETER MEASURED WITHIN THE SPECIFICATION LIMIT OF THE PREVIOUS DRAWING REVISION TO WHICH THIS LOT WAS ORDERED. SINCE THE RAW MATERIAL LOT 5240128 WAS ACCEPTABLE TO BE USED AS IS, (B)(4) IS NOT RELEVANT TO THIS COMPLAINT. (B)(4) WAS GENERATED DUE TO A CERTIFICATE OF TESTS FROM THE SUPPLIER CONTAINING ERRORS. A CORRECTED CERTIFICATE OF TESTS WAS ISSUED BY THE SUPPLIER AND THE RAW MATERIAL WAS ACCEPTABLE. SINCE THE RAW MATERIAL LOT 5861879 MET ALL REQUIREMENTS FOR ACCEPTANCE, (B)(4) IS NOT RELEVANT TO THIS COMPLAINT. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NONCONFORMANCE (B)(4) IS NOT RELEVANT TO THIS COMPLAINT SINCE THE RAW MATERIAL WAS ACCEPTABLE TO BE USED AS IS. NONCONFORMANCE (B)(4) IS NOT RELEVANT TO THIS COMPLAINT SINCE THE RAW MATERIAL MET ALL REQUIREMENTS FOR ACCEPTANCE. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE RETURNED DEVICE (135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 2H-STER) IS AN IMPLANT AVAILABLE FOR USE IN THE LOCKING COMPRESSION PLATE (LCP) DYNAMIC HELICAL HIP SYSTEM (DHHS) USED TO PROVIDE STRONG AND STABLE INTERNAL FIXATION OF A VARIETY OF INTERTROCHANTERIC, SUBTROCHANTERIC AND BASILAR NECK FRACTURES IN WHICH A STABLE MEDIAL BUTTRESS CAN BE RECONSTRUCTED. THIS COMPLAINT IS CONFIRMED. THE RETURNED 9 YEAR OLD SINGLE USE IMPLANT (SIDE PLATE) WAS RECEIVED AT CUSTOMER QUALITY (CQ) WITH A HELIX BLADE LODGED INSIDE OF IT. THE HELIX BLADE WAS UNABLE TO BE REMOVED FROM THE SIDE PLATE BARREL AT CQ. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) VIA FUNCTIONAL TEST IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. FURTHER EXAMINATION UNDER 5X MAGNIFICATION REVEALED MULTIPLE LOCATIONS ON THE UNDERSIDE OF THE PLATE WITH POST MANUFACTURING DAMAGE/WITNESS MARKS RESEMBLING SERRATED TEETH PLIERS. THERE ARE ALSO TWO ADJACENT DENTS ON THE SUPERIOR AND PROXIMAL EDGE OF WHERE THE BARREL MEETS THE PLATE. THE POST MANUFACTURING DAMAGE ON THIS 9 YEAR OLD IMPLANT MAY OR MAY NOT HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. IT IS ALSO POSSIBLE THAT THIS POST MANUFACTURING DAMAGE OCCURRED DURING ATTEMPTED REMOVAL OF THE CONSTRUCT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 135 DEG LCP DHHS SIDEPLATE-STD BARREL 2H STERILE 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. THE MATERIAL WAS DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. A DIMENSIONAL INSPECTION IS NOT POSSIBLE BECAUSE THE FEATURES(S) OF INTEREST RELEVANT TO THIS COMPLAINT ARE NOT ACCESSIBLE DUE TO THE HELIX BLADE BEING LODGED INSIDE THE BARREL. TABULATED DRAWING WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CORRECTED DATA: PRODUCT PROBLEM. 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

    (B)(6). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2017, THE DYNAMIC HELICAL HIP SYSTEM (DHHS) HELICAL BLADE HAD BEEN IMPLANTED AND THE SURGEON WAS IN THE PROCESS OF SLIDING THE SIDE PLATE OVER THE BACK OF THE HELICAL BLADE. THEY STARTED USING THE IMPACTOR TO ADVANCE THE SIDE PLATE AND AFTER 5-6 HITS IT WAS NOTED RADIOGRAPHICALLY THAT THE HELICAL BLADE WAS ADVANCING. AFTER TRYING TO REMOVE THE SIDE PLATE FOR 4-5 MIN THE SIDE PLATE AND THE HELICAL BLADE CAME OUT AS ONE UNIT. THE BARREL OF THE SIDE PLATE BECAME LODGED ON THE HELICAL BLADE. A NEW HELICAL BLADE AND SIDE PLATE WERE THEN IMPLANTED AND THE CASE WAS FINISHED SUCCESSFULLY. THIS EVENT CAUSED A 15 TO 20-MINUTE DELAY IN SURGERY. NO ADDITIONAL X-RAYS AVAILABLE. THE PATIENT OUTCOME WAS NOTED AS STABLE. THIS REPORT IS FOR ONE (1) 135 DEGREE LCP DHHS SIDEPLATE-STANDARD BARREL THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51357 135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 2H-STER APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 282.610S 6071486 10886982178671

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR