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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Non-union Bone Fracture (2369)
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Event Type
Injury
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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.510k: this report is for an unknown 1.3-mm ao plate/screws construct/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.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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This report is being filed after the review of the following journal article: orman o., et al (2021) a new custom-made plate preparation method for bony mallet finger treatment and comparison with extension block technique, jt dis relat surg volume 32(3), pages 617-624 (turkey).This retrospective study aims to describe a new technique for the preparation of mallet plates for use in the treatment of mallet fractures and compared the results with the extension block technique (ebt).Between april 2015 and january 2018, the patients (13 males, 6 females; mean age: 30.9±9.2 years; range, 17 to 48 years) who were diagnosed with mallet finger fractures, treated with ebt or hook plate technique (hpt), and followed for minimum six months were included.A total of 12 patients were treated with ebt and 10 patients were treated with a custom-made hook plate that was contoured from a 1.3-mm ao plate.During follow-up, the number of patients was reduced to nine in the hpt group and to 10 in the ebt group as the remaining patients failed to attend the follow-up appointment.Finally, a total of 19 patients including 10 who were treated with ebt (7 males, 3 females; mean age: 30.1±7.3 years; range, 17 to 48 years) and nine who were treated with hpt (6 males, 3 females; mean age: 31.7±11.3 years; range, 19 to 42 years) were enrolled.Reported complications: patient no.1 had a nail deformity.Additional treatment was not recommended for patients with nail disorders.Patient no.3 had deep severe infection skin breakdown and subsequent loss of reduction.Failure score according to warren score.Debridement and early plate removal were carried out and a temporary joint transfixation was performed with k-wires.Patient no.4 nail deformity.Additional treatment was not recommended for patients with nail disorders.This report is for unknown synthes 1.3-mm ao plate/screws construct.This report captures the patient no.3 who had deep severe infection skin breakdown, and subsequent loss of reduction.Failure score according to warren score.Debridement and early plate removal were carried out and a temporary joint trans-fixation was performed with k-wires.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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