BEUDAMED
    FDA Adverse Event Death Summary report: N

    RICHARDS BONE STAPLES

    MDR report key: 10423232 · Received August 18, 2020

    Report

    Report Number
    1219602-2020-01265
    Event Type
    Death
    Date Received
    August 18, 2020
    Date of Event
    August 11, 2018
    Report Date
    January 8, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H10 H3, H6: THE ALLEGATION WAS BASED UPON A REPORT STUDY CASE FROM OVER EIGHT YEARS AGO. BIO RCI PRODUCTS OF UNCONFIRMED CODE OR LOT NUMBER WERE REFERENCED AS USED IN TREATMENT. NO PRODUCT WAS RETURNED. DUE TO UNAVAILABILITY, EVALUATION WAS LIMITED, BUT RECOLLECTION BY ONE OF THE ATTENDING PHYSICIANS BELIEVED THAT THE PATIENT PASSED DUE TO AN UNRELATED CAUSE. IF FURTHER INFORMATION BECOMES AVAILABLE, THE COMPLAINT MAY BE REVISITED. PER THE INSTRUCTIONS FOR USE, PREPARATION IS CRITICAL FOR EASE OF INSERTION AND SUCCESSFUL ANCHORING. PER INSTRUCTIONS FOR USE: "IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE. THE STARTER MUST BE UTILIZED WITH THE BIORCI SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION. PRIOR TO USE INSPECT THE TIP OF THE DRIVER. IF TIP FLARING IS APPARENT DO NOT USE THE DRIVER. EXCESSIVE FORCE SHOULD NOT BE PLACED ON THE DELIVERY INSTRUMENT. IF HARD BONE IS ENCOUNTERED, THE BIORCI TAP SHOULD BE USED.¿ FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE STORAGE, DEVICE ABILITY, SURGICAL ABILITY, PROCEDURE LOCATION AND TISSUE CONDITION. INFLUENCES THAT COULD COMPROMISE PRODUCT PERFORMANCE OR INTEGRITY INCLUDE: 1. ADHERENCE TO THE INSTRUCTIONS FOR USE RECOMMENDATIONS. 2. USE OF OTHER THAN RECOMMENDED PREP INSTRUMENT SIZE OR TYPES. 3. TAPER OR LARGER HEAD TO BODY DESIGN MISCALCULATION. 4. ENTANGLEMENT WITH OTHER INSTRUMENTS OR DEVICES. 5. STRIPPING OR OVER-TORQUE. 6. DAMAGED PREP INSTRUMENTS. 7. UNEXPECTED BONE DENSITY/CONDITION. THREE YEAR QUERY OF COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE FAMILY REPORTED. BATCH REVIEW WAS UNATTAINABLE WITHOUT A VALID LOT NUMBER REPORTED. INSTRUCTION FOR USE DOCUMENTATION CONTAINS PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. RISK MANAGEMENT FILES CONTAIN THE REPORTED FAILURE. VARIOUS QUALITY CHECKS ARE IN PLACE TO ENSURE THAT THE MATERIAL OF THE DEVICE MEETS REQUIREMENTS DEFINED AND VALIDATED IN THE DESIGN PROCESS. THERE WAS NO INDICATION OF A MATERIAL FACTOR RELATING TO THE REPORTED FAILURE. POST MARKET SURVEILLANCE ACTIVITIES CONTINUE TO MONITOR FAILURE MODES REPORTED. NO EVIDENCE SUGGESTS PRODUCT FROM THIS FAMILY DID NOT PASS REQUIREMENTS UPON RELEASE FOR USE. AT THIS TIME, THERE IS NO EVIDENCE TO SUGGEST A DIRECT LINK BETWEEN PRODUCT USED DURING THE PROCEDURE AND THE PATIENT OUTCOME REPORTED. A NOTIFICATION HAS BEEN SENT TO MANAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CLINICAL STUDY RELATED TO ISCHIOFEMORAL HIP LIGAMENT RECONSTRUCTIONS FOR RECURRENT POSTERIOR TOTAL HIP JOINT DISLOCATIONS USING RICHARDS BONE STAPLES, A PATIENT DIED FOR UNKNOWN REASONS AFTER FOLLOW-UP WITH THE MEDICAL PRACTITIONER. THERE IS NO INFORMATION THAT RELATES THE DEATH TO THE USE OF THE DEVICES AND IT IS KNOWN THAT THE PATIENT HAD PREVIOUS CLINICAL HISTORY RELATED TO HIP ISSUES. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884563 RICHARDS BONE STAPLES DEVICE, GENERAL MEDICAL LDQ SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death