Catalog Number UNK - CONSTRUCTS: EXPERT TIBIA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Skin Irritation (2076); Impaired Healing (2378); No Code Available (3191)
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Event Date 01/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Pma/510k: this report is for an unknown - constructs: expert tibial nail/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary product was not returned.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.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.(b)(4).
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: hessmann, m.H.Et al.(2020), suprapatellar nailing of fractures of the tibia, operative orthopädie und traumatologie, vol.Xx, ages 1-15 ((b)(6)).The objective of this study is to present intramedullary nailing of tibia fractures via a suprapatellar, transarticular approach with the knee joint in 20¿30 degrees of flexion and the use of specific protection tubes to preserve intra-articular structures.Between 2013 and 2015, 17 patients (15 males and 2 females) with an age range between 18 and 67 years (average 32 years) were treated with an expert tibia nail (etn, depuy synthes, (b)(6) usa).Follow-up was between 3 months and 2 years.The following complications were reported as follows: 1 patient's fracture did not heal; therefore, an exchange nail surgery was carried out through a conventional transpatellar tendon approach.3 patients with open fractures needed skin grafting for definitive wound closure.2 patients complained about anterior knee pain and one patient of a tenderness over the surgical scar at the point of entry.This is for an expert tibia nail (etn, depuy synthes, (b)(6) usa).This report is for one (1) unk - constructs: expert tibial nail.This report is 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.
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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.D6: date of implantation is an unknown date between 2013 and 2015.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.(b)(4).
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Search Alerts/Recalls
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