LEG HOLDER, LOW PROFILE

Description of Event or Problem

IT WAS REPORTED THAT THE BELT AND VELCRO CLOSURE NEED TO BE REPLACED. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

Additional Manufacturer Narrative

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9, G3, H6. EVENT DESCRIPTION: IT WAS REPORTED THAT THE BELT AND VELCRO CLOSURE NEED TO BE REPLACED. THE REPORTED EVENT WAS CONFIRMED. THE SUPPLIER EVALUATION REVEALED DAMAGES AT THE VELCRO WHICH ARE MOST LIKELY RESULTING FROM REPEATED USE. CORRECTION, H1 TO N/A ARTHREX PREVIOUSLY SUBMITTED THIS EVENT AS A REPORTABLE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. UPON FURTHER REVIEW AND EVALUATION OF ASSOCIATED RISK DOCUMENTATION, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER 21 CFR 803.

Description of Event or Problem

***UPDATE FROM 18-JUN-2024. THE VELCRO FASTENER DID NOT COME UNDONE DURING A SURGERY. THERE WAS ALSO NO HARM TO A PATIENT. ACCORDING TO THE INFORMATION FROM THE CUSTOMER, THIS IS A PREVENTIVE REPAIR ONLY.