Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.A device history record (dhr) review was conducted: part: 04.008.078s, lot: 2l96112, manufacturing site: (b)(4), release to warehouse date: jan 12, 2019, expiry date: jan 01, 2029.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 04.008.078, lot number: h756978, manufacturing site: (b)(4), release to warehouse date: dec 06, 2018.Manufacturing location: (b)(4), manufacturing date: oct 18, 2018, part number: 04.008.078, 10mm ti hindfoot arthrodesis cann nail ex 240mm/left, lot number: h756978 (non-sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns072585 met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 21012, tialnbri13.00, lot number: h701863, lot quantity: (b)(4).Certified test report supplied by (b)(4) dated jul 30, 2018 was reviewed and determined to be conforming.Lot summary report dated aug 02, 2018 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: nov 05, 2020: dhr reviewed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent revision surgery around 9pm to reposition the expert han nail, expert end cap, spiral blade, and three (3) locking screws.The original procedure was completed on (b)(6) 2020 in the afternoon.The surgeon originally placed the expert han nail but diagnostic imaging showed evidence that the expert han nail remained extramedullary in the mid-distal third of the tibia.This required revision surgery to carry out repositioning of the implants.There was patient consequence.This complaint involves six (6) devices.This report is for (1) expert han 10 le cann l240 tan light gr.This is report 2 of 6 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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