BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.7MM CABLE WITH CRIMP 750MM-STERILE

    MDR report key: 8155548 · Received December 12, 2018

    Report

    Report Number
    2939274-2018-55368
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    September 20, 2018
    Report Date
    September 21, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDQ
    UDI-DI
    20886982182521
    PMA / PMN Number
    K992616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. MANUFACTURING LOCATION: SUPPLIER-PIONEER SURGICAL TECHNOLOGY; INSPECTED, PACKAGED AND RELEASED BY: MONUMENT; RELEASE TO WAREHOUSE DATES: AUGUST 28, 2014 QUANTITY 17 /JANUARY 09, 2015 QUANTITY 7; PART: 298.801.10S; 1.7MM CABLE WITH CRIMP 750MM- STERILE; LOT: P188294 (STERILE); LOT QUANTITY: 24 (TWO BATCHES; 17 AND 7 FOR 24, TOTAL PIECES). PURCHASED FINISHED GOODS TRAVELERS MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEETS, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATES OF CONFORMANCE SUPPLIED BY PIONEER SURGICAL TECHNOLOGY WERE REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATES OF PROCESSING SUPPLIED TO PIONEER SURGICAL BY STERIS FOR PRODUCT STERILIZATION WERE REVIEWED AND DETERMINED TO BE CONFORMING. LABELING PERFORMED BY SUPPLIER AND VERIFIED AT INSPECTION. THIS LOT MET ALL VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT MET ALL VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICES WERE FORWARDED TO RTI SURGICAL FOR INVESTIGATION, WHICH FOUND THE FOLLOWING. INVESTIGATION WAS PERFORMED FOR THE FOLLOWING: PRODUCT DESCRIPTION: TENSIONER, CABLE, SYNTHES. SYNTHES PART: 391.201. LOT: P502506. PRODUCT DESCRIPTION: TENSIONING DEVICE, PROVISIONAL, SYNTHES. SYNTHES PART: 391.884. LOT: P503611. VISUAL INSPECTION FOUND A 1.7MM CABLE (WITH CRIMP, PART NUMBER 400-802, SYNTHES PART NUMBER 298.801) LODGED IN THE TENSIONER. THE CABLE APPEARS TO BE JAMMED BETWEEN THE CHUCK JAWS AND CANNOT BE REMOVED. A LOCKING BIT WAS RETURNED ATTACHED TO THE TENSIONER AND WAS FOUND TO MEET MANUFACTURING SPECIFICATION. THE TENSIONER, CABLE WITH CRIMP, AND NOSE PIECE WERE ROUTED TO INSTRUMENT ASSEMBLY FOR FURTHER EVALUATION. ADDITIONAL INSPECTIONS CONFIRMED THAT THERE ARE BROKEN CABLE STRANDS LODGED WITHIN THE TENSIONER BODY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION OBTAINED IN THIS COMPLAINT INVESTIGATION. PROBABLE ROOT CAUSE SUGGESTS THAT THE CABLE FRAGMENTS LODGED WITHIN THE TENSIONER BODY CAUSED THE CABLE TO BECOME BOUND UP WITHIN THE ASSEMBLY DURING TENSIONING. HOWEVER, WE WERE UNABLE TO CONFIRM WHETHER THE BROKEN CABLE FRAGMENTS WERE FROM A CABLE IN A PRIOR SURGERY, OR IF THEY OCCURRED DURING THE SURGERY ASSOCIATED WITH THIS COMPLAINT. THE DEVICES WERE RETURNED TO CUSTOMER QUALITY. INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE DEVICE WAS ORIGINALLY RETURNED TO CUSTOMER QUALITY WITH THE ATTACHMENT BIT (391.883) AND PROVISIONAL TENSIONING DEVICE (391.884) ATTACHED TO THE CABLE TENSIONER (391.201) WITH A CABLE WITH CRIMP (298.801.10S) STUCK IN THE OVERALL ASSEMBLY. AFTER THE SUPPLIER INVESTIGATION, THE DEVICE WAS RETURNED TO US CQ WITH THE CABLE WITH CRIMP, ATTACHMENT BIT AND PROVISIONAL TENSIONING DEVICE DISASSEMBLED FROM THE CABLE TENSIONER. HOWEVER, STRANDS FROM THE CABLE REMAINED INSIDE THE CABLE TENSIONER. THE CABLE IS ALSO IN MULTIPLE PIECES, AS IT APPEARS TO HAVE BEEN BROKEN OR CUT IN ORDER TO BE DISASSEMBLED FROM THE OTHER DEVICES. BECAUSE THE BROKEN CONDITION APPEARS TO BE A RESULT OF THE DISASSEMBLY OF THE DEVICES, FURTHER INVESTIGATION OF THIS CONDITION WILL NOT BE PERFORMED. THE RECEIVED CONDITION AGREES WITH THE REPORTED CONDITION. FUNCTIONAL TEST: DUE TO THE STRANDS OF CABLE INSIDE THE TENSIONER, AN ATTEMPT TO RE-INSERT THE CABLE (TO REPLICATE THE STUCK CONDITION) WAS NOT ATTEMPTED. DIMENSIONAL INSPECTION: THE DIAMETER OF THE CABLE MEASURED 1.70MM WHICH MATCHES THE REFERENCE DIMENSION OF 1.70MM FROM THE DRAWING. MEASURED USING MITUTOYO CALIPER (CA215P). NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. PROBABLE ROOT CAUSE SUGGESTS THAT THE CABLE FRAGMENTS LODGED WITHIN THE TENSIONER BODY CAUSED THE CABLE TO BECOME BOUND UP WITHIN THE ASSEMBLY DURING TENSIONING. HOWEVER, WE WERE UNABLE TO CONFIRM WHETHER THE BROKEN CABLE FRAGMENTS WERE FROM A CABLE IN A PRIOR SURGERY, OR IF THEY OCCURRED DURING THE SURGERY ASSOCIATED WITH THIS COMPLAINT. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DATE OF MANUFACTURE IS EITHER AUGUST 28, 2014 OR JANUARY 09, 2015. 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 · 0

    UPDATED INFORMATION, THE DATE OF WHEN THE PART WAS IDENTIFIED AS A SYNTHES CABLE. 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

    UPDATE: THE AWARENESS DATE FOR ADDITIONAL INFORMATION IS 12/5/2019. THIS DATE IS WHEN THE PART WAS IDENTIFIED AS A SYNTHES CABLE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE FEMUR ON (B)(6) 2018, THREE (3) HANDLES FOR PERCUTANEOUS THREADED DRILL WERE STRIPPED OUT AND WOULD NOT THREAD INTO THE DRILL GUIDE. ON ONE (1) PERCUTANEOUS THREADED DRILL, THE THREADS WERE STRIPPED AND THE HANDLE WOULD NOT THREAD IN. ONE (1) CABLE TENSIONER, ONE (1) PROVISIONAL TENSIONING DEVICE AND ONE (1) ATTACHMENT BIT WERE USED SIMULTANEOUSLY TO TENSION THE CABLE. THE SURGEON TRIED TO TENSION THE CABLE WITHOUT PULLING THE SLACK FIRST. THE CABLE GOT BOUND IN THE TENSION DEVICE AND WILL NOT COME OUT. SPARE DEVICES WERE AVAILABLE, AND THE SURGERY WAS COMPLETED WITH A FIVE TO SEVEN (5-7) MINUTE SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995303 1.7MM CABLE WITH CRIMP 750MM-STERILE CERCLAGE FIXATION JDQ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 298.801.10S P188294 20886982182521

    Patients

    Seq Age Sex Outcome Treatment
    1