SYNTHES GMBH 3.5MM TI LCP(TM) EXTRA-ARTICLR DISTAL HUMERUS PL 6H/RIGHT; PLATE, FIXATION, BONE
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Catalog Number 04.104.006 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part #: 04.104.006, synthes lot #: h758921, supplier lot #: n/a, release to warehouse date: 13 nov 2018, manufactured by: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on an unknown date the patient was treated with open reduction and internal fixation of open comminuted fracture of the middle and lower 1/3 of the right humerus under anesthesia.After that, the patient did not take regular reexamination and the patient felt that the symptoms improved.The patient felt abnormal activity of the right upper limb without obvious pain and other discomfort, and so on.No obvious improvement was observed after the operation.X-ray showed that the fracture of the right lower humerus was separated, the screw was broken, and a large number of callus was observed around it, and the patient was recommended to be hospitalized again for surgical treatment.Reopening of the original plate, screw removal, autologous iliac bone grafting, fracture reduction and plate internal fixation were performed on (b)(6) 2021.No additional information could be provided.This report is for one (1) 3.5mm ti lcp(tm) extra-articlr distal humerus pl 6h/right.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history lot - part #: 04.104.006, synthes lot #: h758921, supplier lot #: n/a, release to warehouse date: 13 nov 2018, manufactured by: elmira.No ncrs were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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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