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Catalog Number UNK - IMPLANT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are 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.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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This file is a review of the following journal article: carter, t.H., et al (2021) acute distal biceps tendon repair using cortical button fixation results in excellent short- and long-term outcomes a single-centre experience of 102 patients.The bone & joint journal, vol.103-b(7), pages 1284-1291 (united kingdom).The study emphasizes on the short- and long-term outcome following repair using fixation with a cortical button technique.The patients evaluated on course of this study: 102 patients with a mean age of 43 years (19 to 67), including 101 males.The article describes the following procedure: distal biceps tendon repair.The device involved was: unknown orthocord.Complications described: eight patients (7.8%) had a major complication and 34 (33.3%) had a minor complication.Major complications included four patients with an unrecovered nerve injury (3.9%) three with re-rupture (2.9%), and one (1.0%) who required further surgery for excision of symptomatic ho.No patients had a deep infection requiring operative intervention, vascular injury or crps.Minor complications included 27 patients with neuropraxia (26.5%) and seven with superficial infection not requiring surgery (6.9%).
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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Search Alerts/Recalls
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