WRIGHTS LANE SYNTHES USA PRODUCTS LLC BME ELITE(TM) IMPLANT KIT 18 X 18 MM, 2 LEGS; STAPLE, FIXATION, BONE
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Model Number EL-1818S2 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Tissue Damage (2104)
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Event Date 08/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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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It was reported that on (b)(6) 2020 during a midfoot fusion procedure the handle of the bme elite implant kit would not release the staple implant.The issue happened on back to back implant kits, both have the same lot numbers.The gray portion of the inserter handle was taken out to be able to release the staple implant.The implant had to be explanted then reinserted.More soft tissue was exposed however, additional implants used in case were also problematic.There was a surgical delay.The procedure was completed successfully.This report is for one (1) bme elite(tm) implant kit 18 x 18 mm, 2 legs.This is report 4 of 4 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.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 history lot part number: el-1818s2, synthes lot number: mel200041, supplier lot number: n/a, release to warehouse date: 16apr2020, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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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