TAT LIMB HOLDER;2700Q

Description of Event or Problem

CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT 2700Q RESTRAINT. CUSTOMER STATES DURING EDUCATION/TRAINING THAT THE PUSH DOWN PART THAT RELEASES THE BUCKLE BROKE OFF DURING NORMAL USAGE. TM STATES THAT THE DEVICE HAS BEEN USED NUMEROUS TIMES FOR TRAININGS. SOME CONCERN WAS RAISED OVER REPETITIVE/LONG TERM USE AND ANY RECOMMENDED USEFUL LIFE INFORMATION. NO PATIENT INJURY.

Additional Manufacturer Narrative

PRODUCT WAS RECEIVED AND EVALUATED. VISUAL FINDINGS OBSERVED THE SMALL INTERNAL CENTER COMPONENT CORRESPONDING TO THE MIDDLE PRESS AREA IS FRACTURED AND SEPARATED FROM THE MAIN BUCKLE BODY. THE FRACTURE SURFACE APPEARS CLEAN, WITH NO OBVIOUS DISCOLORATION OR DEFORMATION VISIBLE. THE WEBBING STRAP IS INTACT WITH NO EVIDENCE OF TEARS, CUTS, FRAYING, OR EXCESSIVE WEAR. EVALUATION OF THE RETURNED DEVICE INDICATES THAT THE QUICK-RELEASE BUCKLE IS CAPABLE OF SECURING AND RELEASING WHEN ENGAGED AND MANUALLY ACTUATED. HOWEVER, DUE TO THE MISSING CENTER RELEASE COMPONENT, THE BUCKLE NO LONGER REPRESENTS THE INTENDED THREE-POINT RELEASE DESIGN, WHICH REQUIRES SIMULTANEOUS ACTIVATION OF ALL THREE POINTS, TWO SIDE TABS AND THE CENTER PRESS FEATURE FOR PROPER USE. DESPITE THE FRACTURED INTERNAL CENTER COMPONENT, THE AFFECTED BUCKLE CONTINUES TO LATCH PROPERLY WHEN THE MALE AND FEMALE ENDS ARE CONNECTED AND CAN BE DISENGAGED THROUGH ACTIVATION OF THE RELEASE MECHANISM. INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES BEFORE EACH USE, CHECK CUFFS AND STRAPS FOR CRACKS, TEARS, AND/OR EXCESSIVE WEAR OR STRETCH, CRACKED OR BROKEN BUCKLES OR LOCKS, AND/OR THAT HOOK-AND-LOOP ADHERES SECURELY, AS THESE MAY ALLOW PATIENT TO REMOVE CUFF. ADDITIONALLY, THE IFU WARNS DO NOT USE THIS DEVICE ON A PATIENT WHO IS OR BECOMES: SUICIDAL, HIGHLY AGGRESSIVE OR COMBATIVE, SELF-DESTRUCTIVE, OR DEEMED TO BE AN IMMEDIATE RISK TO OTHERS, UNLESS THE PATIENT IS UNDER CONSTANT SUPERVISION. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE (B)(4).