Additional narrative: patient information is not available for reporting.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Steril: 442.531s - l286248; manufacturing location: (b)(4); supplier: (b)(4); manufacturing date: 31.Jan.2017; expiry date: 01.Jan.2027.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.Not steril: 442.531 - l247607; manufacturing location: (b)(4); manufacturing date: 04.Jan.2017.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.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.Manufacturing location: (b)(4); manufacturing date: 08-apr-2016.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 procedure to repair a distal ulna fracture on (b)(6) 2017, the drill guide would not secure in three (3) holes of the locking compression plate (lcp) distal ulna plate.Surgeon drilled the three (3) holes without the use of the drill guide.The locking screws were inserted; surgeon is concerned for the strength of the fixation.Surgery was delayed approximately 30 minutes.Concomitant devices reported: drill guide (part number unknown, lot number unknown, quantity 1), locking screw (part number unknown, lot number unknown, quantity unknown) this report is for one (1) lcp distal ulna plate.This is report 1 of 1 for (b)(4).
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