SynReam Medullary Reamer Head Ø 8.5 mm 의 안전성 경고

Safety alert

2013-12-24

2013-12-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131224.html

Medical device safety alert: synthes synream medullary reamer head ø 8.5 mm medical device manufacturer, synthes, has issued a medical device safety alert concerning its synream medullary reamer head ø 8.5 mm [part no.: 352.085; lot no.: 15392 through 19396, 24613 through 25347, 1448284 through 2087630]. the manufacturer is initiating a product recall related to the referred part and lot numbers of the synream medullary reamer head ø 8.5 mm. the possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material. there are two potential patient harms associated with the breakage of the reamer head. significant surgical delays (greater than 15 minutes) could result due to the presence of a reamer head that breaks during use. secondary incisions and x-rays may be required to aid in and confirm device removal. in addition, the reamer head is composed of non-implant grade material therefore the retention of non-implant grade material can result in minor bone damage where additional intervention is optional but not required. in a worst case scenario there is the potential for an adverse tissue reaction to occur. in this situation the patient will be symptomatic requiring treatment. the manufacturer advises affected users to take the following actions:- return all unused affected sets to the manufacturer for credit or replacement. inspect their inventory and remove all affected devices from use. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 december 2013.