Catalog Number 201.932 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
No Code Available (3191)
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Event Date 02/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient age at time of event and date of birth are unknown.(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the reporting facility.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.(b)(4).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 reported an event in (b)(6) as follows: it was reported that during an unspecified mandible surgery on (b)(6) 2017, the 2.0mm intermaxillary fixation (imf) 12mm length screw broke during blood suctioning and the tip was retained in the patient¿s jaw.The free fragments were removed by suction.The surgeon removed the retained fragment successfully with a small chisel and other instruments.When the surgeon attempted to place a second 2.0mm imf 8mm screw in the patient¿s upper jaw, the screw began to bend and the surgeon was unable to place it.A drill bit was used the place the remaining screws.The surgery was delayed for 20 minutes due to the reported events.Initially, the patient had an unspecified accident on an unknown date and was on the ultimate controlling institutional unit (uci unit) before surgery.The patient postsurgical outcome was reportedly stable.Reported concomitant devices: chisel (part / lot: unknown, quantity: 1).Drill (part / lot: unknown, quantity: unknown.This report is 1 of 2 for (b)(4).
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Manufacturer Narrative
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Manufacturing location: (b)(4).Manufacturing date: october 26, 2015.No non-conformance reports 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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Updated concomitant device: drill (part: 317.780, lot: f-18267, quantity: 1).
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Search Alerts/Recalls
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