Root cause analysis: part number 30-058 is supplied to deroyal industries, inc.By (b)(4).The actual product is manufactured at carwild's facility (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).Because there was no detection of thread attachment failures and no material changes have been made during the process, it was determined the root cause is not the manufacturing process.The design of the product is that the string is available for location of the sponge (versus sponges without string); however, the string is not meant to be used to remove or relocate the sponge in situ (this is stated in the ifu).Therefore, (b)(4) has stated the root cause for the string detachment is usually associated with improper use of the device by using the string to relocate or remove the device.Corrective action and/or systemic correction action taken: in its scar response, (b)(4) has stated no correction action has been identified to be required at this time.Post-market evaluation was reviewed and no defect related to this issue was found by the end of 2014.No actions were required to be added to the risk assessment evaluation according with the post-market results specific for this type of defect.Medsorb dominicana has indicated heighted awareness of the defect occurrence has been documented and personnel working with this product have been informed.Investigation summary (b)(4) was received reporting that the string of a neuro pad (part number 30-058) is detaching.Because the product is supplied to deroyal, a scar was issued to the manufacturer.In its response to the scar, medsorb dominicana stated the device history record was reviewed for the reported lot numbers.No issues were found relating to the string detaching during the manufacturing process.In its scar response, (b)(4) indicated thread attachment is evaluated 8 pieces per sonic machine at the beginning of each work order and then each hour taken 8 pieces per the sonic machine.Thread attachment must be equal to or greater than 1.0 lb force.All data was found to be between 1.34-4.12 lbs in lot number 11a0113.All data was found between 1.33 and 3.9 lbs in lot number 14a0079.(b)(4).Preventive action: no preventive action has been taken at this time.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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