SYNTHES SELZACH 1.1MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.; DRILL, BONE, POWERED
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Catalog Number 317.220S |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Date of device breakage is not known.Additional product codes: erl, hbe.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 18.Nov.2016 expiry date: 01.Nov.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 317.220 / f-17998 was manufactured in (b)(4), manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 23.Dec.2015.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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Event Description
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Device report from synthes europe reports an event in the (b)(6) as follows: it was reported the drill bit snapped and broke during unknown surgical procedures, resulting in additional case time and extra exposure from x-ray to retrieve the broken fragment.Initial occurrence is addressed in (b)(4).This report addresses the additional occurrence.Concomitant device reported: drill (part number unknown, lot number unknown, quantity 1).This report is for one (1) 1.1mm drill bit.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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(b)(6).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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Search Alerts/Recalls
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