Additional narrative: 510k: this report is for an unknown multilock humeral nail constructs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.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.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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This report is being filed after the review of the following journal article: boyer, p.Et al.(2021), displaced three and four part proximal humeral fractures: prospective controlled randomized open-label two-arm study comparing intramedullary nailing and locking plate, international orthopaedics, vol.45, pages 2917-2926 (france).The aim of this study was (1) to compare clinical and radiological outcomes of 3- and 4-part proximal humeral fractures using either imn or lp (2) and to report complications related to each technique.Between january 2012 and december 2015, a total of 99 patients underwent surgical procedure for 3- and 4-part proximal humeral fractures.50 patients underwent a locking plate procedure and 49 patients underwent an imn procedure using a straight humeral nail (multiloc nail, depuy synthes, warsaw, usa).The mean age was 73.7 years (± 13.3,, and the mean follow-up was 66 months.The following complications were reported as follows: 1 patient died.2 patients had nonunion which was revise with rsa and reaming + imn.2 patients had avascular necrosis which was revised with rsa.2 patients had humeral impingement which required hardware removal.1 patient had an infection which was washed-out.2 patients had screw cut-through which required removal.This report is for an unknown synthes multiloc nail constructs.This report captures the reported 2 patients who had nonunion which was revise with rsa and reaming + imn, 2 patients who had avascular necrosis which was revised with rsa, 2 patients who had humeral impingement which required hardware removal and 1 patient had an infection which was washed-out.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).
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