Catalog Number 188319326 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2023 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in china as follows: it was reported that during the surgery on (b)(6) 2023, the devices¿ inner core was expulsion.Another device was used to complete the surgery.There were no adverse consequences to the patient.No surgical delay reported.No additional information could be provided.This report is for mntr m/l screw 3.5 dia x 26 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: 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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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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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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.A review of the receiving inspection (ri) for mntr m/l screw 3.5 dia x 26, was conducted identifying that lot number 195701 was released in two batches.Batch1: released on 06 june 2018 with no discrepancies.Batch2: released on 22 june 2018 with no discrepancies.Supplier : (b)(4).The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the head cap from the mntr m/l screw 3.5 dia x 26 was observed to be separated.The cap was returned for examination, and it was observed that the circumference of the cap is bent and with signs of scraping.This condition could have contributed to the cap separating from the device.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was unable to be performed due to post manufacturing damage.The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the mntr m/l screw 3.5 dia x 26 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed.Current and manufactured revisions were reviewed.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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Search Alerts/Recalls
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