Additional narrative: patient identifier and weight are not available for reporting.Additional code: hwc.Two (2) possible lot numbers reported.Lot number 9902157, manufacture date april 8, 2016, expiration date march 1, 2026.(b)(4).Lot number l039203, manufacture date june 27, 2016, expiration date june 1, 2026.(b)(4).Device was not implanted or explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device, part 03.226.039, partial lot number l225x4.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Article 02.226.001s with lot 9902157 please note, this dhr review is for sterilization procedure only manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 08.Apr.2016 expiry date: 01.Mar.2026.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 02.226.001 / 9879022.Manufacturing location: (b)(4), manufacturing date:11.Mar.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Article 02.226.001s with lot l039203.Please note, this dhr review is for sterilization procedure only, manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 27.Jun.2016 expiry date: 01.Jun.2026.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 02.226.001 / 9965823.Manufacturing location: (b)(4), manufacturing date: 24.May.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 synthes europe reports an event in (b)(6) as follows: it is reported during a calcaneal fracture procedure on (b)(6) 2017; while surgeon was drilling a guide wire broke.The broken fragment remains embedded in the patient.Surgeon used another guide wire to insert a screw and used a jacobs chuck when inserting the guide wire.No surgical delay or need for other medical intervention was required.Patient status reported as good.Concomitant devices reported: jacobs chuck (part number unknown, lot number unknown, quantity 1), drill bit (part 03.226.039, lot number unknown, partial lot l225x4, quantity 1), screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) guide wire.This is report 1 of 1 for (b)(4).
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