CRUTCH: ALUMINUM, ADULT TALL

Description of Event or Problem

PATIENT WITH AN IMPAIRED FOOT WAS WALKING USING CRUTCHES WHEN A PLASTIC ADJUSTMENT BOLT BRACKET AT THE DISTAL END OF THE CRUTCH BROKE, CAUSING THE CRUTCH TO FAIL. THE PATIENT STUMBLED AND LANDED ON THE UNIMPAIRED FOOT BUT SUFFERED NO INJURY AS A RESULT. NO FURTHER TREATMENT OR MEDICAL FOLLOW-UP WAS REQUIRED FOR THIS INCIDENT.

Additional Manufacturer Narrative

MEDICAL ACTION INDUSTRIES ("MAI") IS THE IMPORTER OF THE CRUTCH, NOT THE ACTUAL MANUFACTURER; HOWEVER, MAI'S NAME AND CONTACT INFO ARE ON THE CRUTCH LABELING. ON (B)(4) 2014, MAI RECEIVED INFO AND PHOTOS FROM THE DISTRIBUTOR, NATIONAL DISTRIBUTION AND CONTRACTING, THAT A PATIENT WAS USING AN MAI CRUTCH WHEN IT BROKE. MAI IMMEDIATELY OPENED COMPLAINT #(B)(4) FOR THIS ISSUE AND BEGAN AN INVESTIGATION. THE PT'S PARENT CONFIRMED THAT THERE WAS NO INJURY AS A RESULT OF THE INCIDENT; HOWEVER, THE NON-BROKEN CRUTCH WENT THROUGH THE WALL, MAKING A SMALL HOLE IN WALL. AS A RESULT, THE PATIENT'S FAMILY REQUESTED MAI PAY $(B)(4) FOR REPAIR OF THE WALL. MAI SENT CHECK FOR $(B)(4) FOR WALL REPAIR TO FAMILY ON (B)(4) 2014. MAI RECEIVED THE COMPLAINT CRUTCH AND CONFIRMED THE ISSUE: THE PLASTIC BRACKET AT THE DISTAL END THAT HELPS HOLD THE BOLTS IN PLACE WAS BROKEN. MAI IMMEDIATELY SENT THE DEFECTIVE CRUTCH TO EASYTEC, THE ACTUAL MANUFACTURER, ALONG WITH SUPPLIER CORRECTIVE ACTION REQUEST (SCAR #(B)(4)) TO PROVIDE ROOT CAUSE AND CORRECTIVE ACTIONS. ON (B)(4) 2014, MAI RECEIVED SCAR RESPONSE FROM EASYTEC WHICH PROVIDED THE FOLLOWING INFO: ROOT CAUSE: EASYTEC'S BRACKET SUPPLIER ADDED TOO MUCH (B)(4) RECYCLING MATERIAL IN PRODUCTION OF PLASTIC BRACKETS, AND DID NOT PUT FINISHED BRACKETS "ON WATER" (TO PROVIDE STRENGTH). CORRECTIVE ACTIONS: EASYTEC INSTRUCTED THEIR SUPPLIER THAT THEY SHOULD ONLY ADD (B)(4) RECYCLING MATERIAL TO PLASTIC FORMULATION INSTEAD OF (B)(4). AFTER FINISHING THE BRACKETS, SUPPLIER SHOULD "PUT IT ON THE WATER" FOR 30 MINUTES TO INCREASE ITS STRENGTH. UPON RECEIPT OF FINISHED BRACKETS, EASYTEC WILL VERIFY THE STRENGTH OF EACH TO ENSURE IT WILL NOT BREAK. ANY BRACKETS THAT BREAK WILL BE RETURNED TO THE SUPPLER. THESE IMPROVEMENTS BEGAN ON (B)(4) 2014. TO DATE, MAI HAS NOT RECEIVED ANY ADDITIONAL COMPLAINTS FOR THIS LOT. MAI DOES NOT HAVE ANY INVENTORY OF THIS CRUTCH - IT IS SHIPPED DIRECTLY FROM EASYTEC TO (B)(4), THE DISTRIBUTOR. ALL TEAM MEMBERS WERE NOTIFIED OF THIS COMPLAINT FOR HEIGHTENED AWARENESS. THIS COMPLAINT HAS BEEN ENTERED INTO OUR COMPLAINT DATABASE FOR TRACKING AND TRENDING PURPOSES.