CRUTCH,ALUMINUM,ADULT,TALL,LF,300LB

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE TIP OF A CRUTCH RIPPED DURING USE RESULTING IN THE CUSTOMER FALLING, DAMAGING HIS ACHILLES TENDON AND REQUIRING SURGERY. THE CUSTOMER REPORTED THAT HE INITIALLY HAD AN ACHILLES TENDON INJURY ON (B)(6) 2017 AND WAS GIVEN THE CRUTCHES AT THE HOSPITAL. ON (B)(6) 2017 THE CUSTOMER REPORTED THAT HE WAS TRYING TO STAND UP USING THE CRUTCHES AND THE CRUTCH SLIPPED OUT FROM UNDER HIM RESULTING IN THE CUSTOMER FALLING ON THE HARDWOOD FLOOR. PER THE CUSTOMER, AFTER AN MRI EVALUATION HE UNDERWENT SURGERY FOR THE REPAIR OF A RE-RUPTURED ACHILLES TENDON. THE CUSTOMER REPORTED THAT HE CURRENTLY DOES NOT USE ANY ASSISTIVE DEVICE AND HE IS WALKING INDEPENDENTLY. THE SAMPLE WAS RETURNED FOR EVALUATION. UPON INVESTIGATION OF THE DEVICE, THE SAMPLE WAS FOUND TO BE IN USED CONDITION. ONE CRUTCH HAD THE ADJUSTABLE CRUTCH LEG PROTRUDING THROUGH THE CENTER OF THE BOTTOM FACE OF THE TIP. IT IS NOT KNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE FALL; HOWEVER THE CUSTOMER REPORTED ISSUE OF A RIPPED CRUTCH TIP WAS CONFIRMED. A ROOT CAUSE HAS NOT BEEN DETERMINED. DUE TO THE REPORTED INCIDENT AND SUBSEQUENT NEED FOR SURGICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF A CRUTCH RIPPED DURING USE.