|
Additional information: d9, g3, h3, h6 d10 concomitant product: vp-754-x, vp-754-x surgipro*ii 6-0 blu 60cm cv20da, (lot #d9k2116y) correction: g1 h3 evaluation summary: medtronic conducted an investigation based upon all information received.A three representative samples opened by the account with the appropriate packaging and two hundred and twelve sealed were available for evaluation.Visual inspection noted on sealed samples: a tactile and microscopic inspection of the sutures was performed with no abnormalities.Microscopic inspection of the needles noted no abnormalities.Moreover, the visual inspection of the open samples noted three sutures and six needles.The two needles were received broken.One was broken one third of the needle length from the tip and one halfway along the needle length.Three needles were received bent along the length of the needles.Upon microscopic inspection of the needle, normal crimp and swage marks were noted.No instrument marks were noted at the bend and break sites.Functional testing found no notable condition related to reported condition.It was reported that the needle was broken.The reported issue could not be confirmed.The most likely cause could not be established from the information available.A review of the device history records found potentially contributing factors from the manufacturing process.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
