BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACTPIN GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432MM (.093 X 17IN)

    MDR report key: 6399253 · Received March 13, 2017

    Report

    Report Number
    1017294-2017-00018
    Event Type
    Injury
    Date Received
    March 13, 2017
    Date of Event
    February 14, 2017
    Report Date
    March 13, 2017
    Manufacturer
    CONMED CORPORATION
    Product Code
    GFG
    UDI-DI
    20845854041748
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) USED/DAMAGED XACTPIN GRAFT PASSING GUIDE PIN WAS RECEIVED FOR EVALUATION ON 09-MAR-2017. VISUAL INSPECTION OF THE RETURNED DEVICE BY THE ENGINEER FOUND THE PIN HAD BROKEN OFF AT THE LASER ETCH LINE DISTALLY FROM THE NECK AND THE BROKEN PORTION WAS NOT RETURNED. THIS FAILURE IS INDICATIVE OF A BENDING LOAD BEING PLACED ON THE DEVICE AS THIS IS THE STRONGEST STRESS CONCENTRATION LOCATION FOR A BENDING LOAD. BASED ON AVAILABLE INFORMATION, IT IS BELIEVED THAT THE MOST PROBABLE CAUSE OF THE PIN BREAKAGE IN THIS INSTANCE IS USE RELATED, AND A PROBABLE RESULT OF MISUSE. THIS LOT #804887 WAS MANUFACTURED ON 30-JAN-2017. OF THE LOT CONTAINING (B)(4) UNITS, THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED, THERE WERE NO ANOMALIES OR NONCONFORMANCES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED PROBLEM. IN ADDITION, A 2-YEAR REVIEW OF THE PRODUCT HISTORY SHOWS OTHER THAN THIS COMPLAINT, THERE HAVE BEEN NO OTHER SIMILAR REPORTS OF BREAKAGE RECEIVED. (B)(4). TO DATE, THERE HAVE BEEN NO PATIENT LONG TERM ADVERSE EFFECTS RESULTING FROM THIS TYPE OF INCIDENT. THIS FAILURE MODE IS ADDRESSED IN THE DFMEA, AND THE SAFETY RISK HAS BEEN FOUND TO BE ACCEPTABLE. XACTPIN GRAFT PASSING GUIDE PIN - STERILE IS USED DURING SOFT TISSUE REPAIRS, INCLUDING CRUCIATE LIGAMENT REPAIRS/RECONSTRUCTIONS, TO FACILITATE THE POSITIONING OF CANNULATED DRILLS OR REAMERS, PASSING OF A SOFT TISSUE GRAFT THROUGH BONE TUNNEL, AND REFERENCING OF THE TUNNEL LENGTH. TO REDUCE THE RISK OF GUIDE PIN BREAKAGE AND INJURY TO THE PATIENT, THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: - USE CAUTION WHEN HANDLING TO AVOID INJURY. - NEUROVASCULAR STRUCTURES MUST BE AVOIDED WHEN ADVANCING THIS DEVICE. - THIS DEVICE SHOULD NOT BE ADVANCED WITH A MALLET. - PROPER KNEE FLEXION ANGLES SHOULD BE CONFIRMED PRIOR TO ADVANCEMENT. - LEG HOLDER SHOULD BE PLACED HIGH ON THE LEG ALLOWING ADEQUATE EXPOSURE FOR PIN EXIT. - INSPECT PIN PRIOR TO USE TO ENSURE IT IS IN GOOD PHYSICAL CONDITION AND FUNCTIONS PROPERLY. DO NOT USE IF PRODUCT IS DAMAGED - DO NOT BEND THE XACTPIN GRAFT PASSING GUIDE PIN PRIOR TO OR DURING INSERTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE XACTPIN GRAFT PASSING GUIDE PIN 2.4 MM X 432 MM IN AN ACL REPAIR PROCEDURE, THE PIN BROKE OFF AND BECAME LODGED IN THE PATIENT'S BONE. FOLLOW-UP WITH THE USER FACILITY REVEALED THAT THE SURGEON WAS PERFORMING TRANSTIBIAL ACL PROCEDURE AND WAS DRIVING THE PIN THROUGH THE FEMUR AND SUBSEQUENTLY THE BREAKAGE OCCURRED WHEN THE GUIDE PIN WAS REMOVED FROM THE FEMUR. ATTEMPT TO REMOVE THE BROKEN PORTION OF THE PIN FAILED, AS THE PIECE WAS LODGED IN FEMORAL CANAL AND COULD NOT BE REMOVED. AS THE PROCEDURE WAS COMPLETED AND PRIOR TO CLOSING, X-RAY WAS TAKEN AND CONFIRMED THE PIN WAS STILL IN THE PATIENT. OTHER THAN A 30-MINUTE DELAY REPORTED, THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO OTHER SERIOUS INJURY TO THE PATIENT. DESPITE THE GOOD FAITH EFFORTS, NO PATIENT DEMOGRAPHIC INFORMATION COULD BE OBTAINED FROM THE USER FACILITY. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182361 XACTPIN GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432MM (.093 X 17IN) BIT, SURGICAL GFG CONMED CORPORATION 804887 20845854041748

    Patients

    Seq Age Sex Outcome Treatment
    1 Other