BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR BIORCI-HA 9X30 STERILE

    MDR report key: 8153249 · Received December 11, 2018

    Report

    Report Number
    1219602-2018-01731
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 28, 2018
    Report Date
    August 10, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    UDI-DI
    03596010460011
    PMA / PMN Number
    K002274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE STERILE 7207682 9X30MM BIORCI HA SCREW USED FOR TREATMENT, WAS RETURNED FOR EVALUATION. ATTEMPT TO GATHER FURTHER INFORMATION OR PHOTO WAS UNSUCCESSFUL. THE PROXIMAL AREA IS IN BETTER CONDITION THAN DISTAL. THREADS HAVE BEEN COMPRESSED AND ROLLED FROM HEAVY RESISTANCE. THESE SYMPTOMS ARE CONSISTENT WITH PRESSURE/FORCE DURING INSERTION. AN INADEQUATE TUNNEL MAY CAUSE OUTER DIAMETER SKIVING OFF OF COMPROMISED THREADS. PREP SPECIFIC TO IFU 1061039 IS ESSENTIAL FOR SUCCESS OF THIS PRODUCT. UNDER MAXIMUM SURFACE TO SURFACE INTENT IS ACHIEVED WITH INTERFERENCE STYLE SCREWS BY USE OF SAME SIZE TUNNEL ALLOWING THE SCREW THREADS TO MAKE OPTIMUM SURFACE TO SURFACE CONTACT. A SMALLER TUNNEL INCREASES THE RISK OF TORQUE DAMAGE. IF DIFFICULTY WITH INSERTION OCCURS, A TAP SHOULD BE CONSIDERED FOR UNEXPECTED BONE DENSITY. COMPLAINT SEARCH REVEALED NO OTHER COMPLAINTS FOR THE HISTORY OF THIS PRODUCTION LOT. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. MIMB REVIEW: ASSESS SEVERITY OF COMPLAINT CASE TO DETERMINE IF ADDITIONAL ACTION AND FURTHER INPUTS ARE REQUIRED FOR INCLUSION IN MEDICAL ASSESSMENT. DETERMINE IF A MEDICAL ASSESSMENT WOULD BE PERFORMED BASED ON A REVIEW OF THE COMPLAINT DETAIL AND FURTHER RECOMMENDATIONS FROM THE MEDICAL DIRECTOR/DESIGNEE. REVIEWED DURING MIMB. A MEDICAL INVESTIGATION WILL BE PERFORMED. PROCEED BASED ON INFORMATION PROVIDED OR AVAILABLE FOR THE INVESTIGATION; IF NO RELEVANT CLINICAL INFORMATION IS PROVIDED, RECOMMEND CLOSURE. APPROVED BY DR. (B)(6), MEDICAL DIRECTOR. A REVIEW OF RELEVANT CLINICAL/MEDICAL INFORMATION IN THE REPORTED ISSUE, INCLUSIVE OF TECHNIQUE AND PATIENT INFORMATION, TO INCLUDE, BUT NOT LIMITED TO: PATIENT INFORMATION. SURGICAL PROCEDURE/POST-OPERATIVE CARE REVIEW. DEVICE LABELING (INCLUDING TECHNIQUE GUIDES, IFUS, ETC.). REPORTEDLY DURING A PROCEDURE THE THREAD OF THE SCREW DAMAGED THE TENDON AND BROKE WHILE INSIDE THE PATIENT. PER E-MAIL COMMUNICATION IT IS UNKNOWN IF BROKEN PIECE WAS REMOVED. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES. PER PRODUCT ANALYSIS THE THREAD ON THE SCREW HAD BEEN COMPRESSED AND ROLLED FROM HEAVY RESISTANCE. THESE SYMPTOMS ARE CONSISTENT WITH PRESSURE/FORCE DURING INSERTION. AN INADEQUATE TUNNEL MAY CAUSE OUTER DIAMETER SKIVING OFF OF COMPROMISED THREADS. PREP SPECIFIC TO IFU 1061039 IS ESSENTIAL FOR SUCCESS OF THIS PRODUCT. UNDER WARNINGS, THE IFU SAYS: ¿THE STARTER MUST BE UTILIZED WITH THE BIORCI¿HA SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION¿. ¿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¿. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED. CONCLUSION: IF A BROKEN PORTION OF THE BIOSURE SCREW WAS RETAINED, THE MATERIAL IS MADE OF A BIOCOMPOSITE MATERIAL WHICH IS INTENDED FOR IMPLANTATION TO ALLOW FOR BONE INGROWTH. HOWEVER, IT IS UNKNOWN IF THE BIOSURE SCREW WILL MIGRATE. BASED ON THE PRODUCT EVALUATION THE ROOT CAUSE OF THE SCREW BREAKAGE WAS A USER VS PROCEDURAL EVENT DUE TO PRESSURE/FORCE DURING INSERTION. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. APPROVED BY (B)(6), MD (B)(6) 2019 ¿IMDR: E2008, E1620, F26¿.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    ONE STERILE BIORCI HA 9X30MM SCREW REPORTED ON. DUE TO PRODUCT UNAVAILABILITY, PHYSICAL EVALUATION, FULL INVESTIGATION AND CONCLUSIONS WERE NOT POSSIBLE. FACTORS AFFECTING DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY AND SURGICAL SITE PREPARATION ACCORDING TO INSTRUCTIONS FOR USE. INSTRUCTIONS FOR USE CONFIRMS INSTRUCTIONS, RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS AND FOR PROPER USE OF PRODUCT. INFLUENCES THAT COULD COMPROMISE PRODUCT INTEGRITY INCLUDE: 1. USE OF DAMAGED OR OTHER THAN RECOMMENDED PREP INSTRUMENT SIZE AND/OR TYPES. 2. NOT ACCOUNTING FOR TAPER OR LARGER HEAD TO BODY DESIGN. 3. ENTANGLEMENT WITH GUIDE WIRE OR OTHER INSTRUMENT CAUSING TEARING AND FRACTURES. 4. UNEXPECTED BONE DENSITY/CONDITION. 5. USE OF EXCESS TORQUE OR FORCE. REVIEW OF INSTRUCTION FOR USE DOCUMENTATION CONFIRMS INSTRUCTIONS, PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. THE INSTRUCTIONS FOR USE RECOMMENDATION IS CRITICAL FOR EASE OF INSERTION AND SUCCESSFUL ANCHORING. ¿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.¿ FINAL PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    ONE 7207682 STERILE BIORCI HA 9X30MM SCREW REPORTED ON. DUE TO PRODUCT UNAVAILABILITY, PHYSICAL EVALUATION, FULL INVESTIGATION AND CONCLUSIONS WERE NOT POSSIBLE. INFLUENCES THAT COULD COMPROMISE PRODUCT INTEGRITY INCLUDE: USE OF DAMAGED OR OTHER THAN RECOMMENDED PREP INSTRUMENT SIZE AND/OR TYPES. NOT ACCOUNTING FOR TAPER OR LARGER HEAD TO BODY DESIGN. ENTANGLEMENT WITH GUIDE WIRE OR OTHER INSTRUMENT CAUSING TEARING AND FRACTURES. UNEXPECTED BONE DENSITY/CONDITION. USE OF EXCESS TORQUE OR FORCE. FINAL PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. A REVIEW OF RELEVANT CLINICAL/MEDICAL INFORMATION IN THE REPORTED ISSUE, INCLUSIVE OF TECHNIQUE AND PATIENT INFORMATION, TO INCLUDE, BUT NOT LIMITED TO: PATIENT INFORMATION, SURGICAL PROCEDURE/POST-OPERATIVE CARE REVIEW, DEVICE LABELING (INCLUDING TECHNIQUE GUIDES, IFUS, ETC.). IT WAS COMMUNICATED VIA EMAIL THAT DUE TO PRIVACY REASONS, OPERATIVE NOTES AND PHOTOS OF RADIOLOGICAL IMAGING ARE NOT AVAILABLE. THEREFORE BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD OF THE SCREW BROKE CAUSING A DAMAGE TO THE TENDON. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD OF THE SCREW DAMAGED THE TENDON AND BROKE IT. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989695 SCR BIORCI-HA 9X30 STERILE SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 50671999 03596010460011

    Patients

    Seq Age Sex Outcome Treatment
    1