SYNTHES GMBH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/26MM-STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 412.109S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 12/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: 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 (b)(6) 2021, the patient underwent open reduction internal fixation surgery for fracture of proximal end of left humerus.The surgery was completed successfully without any surgical delay.After the surgery, on (b)(6) 2021, it was confirmed that reduction position had collapsed, and bone fragments had fallen out of the implants.The cause of this event is unknown, and the removal surgery of the implants will be performed on (b)(6) 2021.No further information is available.This report is for one (1) 3.5mm ti locking scr slf-tpng w/star drive recess/26mm-ster.This is report 5 of 9 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: a device history record (dhr) review was conducted: part # 412.109s.Lot # 31p5962.Manufacturing site: grenchen.Release to warehouse date: 10 january 2020.Expiry date: 01 december 2029.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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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