WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® COMPRESSION SCREW 36MM; APPLIANCE,FIXATION,NAIL
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Model Number 280.990 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
Not Applicable (3189)
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Event Date 03/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Implant and explant dates: implant and explant date not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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It was reported that while attempting to implant the dhs/dcs compression screw during a case on (b)(6) 2018 the last few turns became very difficult.On the last turn the set screw (head of the dhs/dcs screw) snapped off and was discarded.The remainder of the compression screw remains implanted.Proper compression was achieved, and the product performed as expected.No surgeon follow up required.There was no surgical delay, and the patient's outcome was reportedly good.There is one device involved in this complaint.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Device is a single use device but was not reprocessed or reused.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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