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Model Number 03.010.227 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
Event Type
malfunction
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Event Description
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Device report from depuy synthes reports an event in canada as follows: it was reported that one of the cams does not spring loan and lock onto sleeve, it was noticed that the spring is missing.There were no surgical delay and the procedure was completed successfully.It was also noted that this item is not repairable.This complaint involves one(1) device.This report is for one (1) aiming arm for adolescent lfn nail-ex this is report 1 of 1 for complaint pc-(b)(4).
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Manufacturer Narrative
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Product complaint #pc-(b)(4).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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation.Reporters phone number: (b)(6).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.H10 additional narrative: h3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Part number: 03.010.227, lot number: 46p8036, manufacturing site: haegendorf, release to warehouse date: 18 august 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment attachment.Visual analysis of the photo revealed that aiming arm for adolescent lfn nail-ex had the golden knob locking cam separated from the rest of the device and missing the internal spring.Assembling issues are most likely due to this condition.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for aiming arm for adolescent lfn nail-ex.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.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.D9.
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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.Part number: 03.010.227.Lot number: 46p8036.Manufacturing site: haegendorf.Release to warehouse date: 18 august 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 aiming arm for adolescent lfn nail-ex had the golden knob locking cam separated from the rest of the device and missing the internal spring, the assembling issues are most likely due to this condition.A dimensional inspection for the aiming arm for adolescent lfn nail-ex was unable to be performed due to dimensions not being applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 aiming arm for adolescent lfn nail-ex 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 the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -aiming arm adolescent lateral entry femoral nail rev f current and manufactured.Dimensional inspection: n/a.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.Part number: 03.010.227.Lot number: 46p8036.Manufacturing site: haegendorf.Release to warehouse date: 18 august 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 aiming arm for adolescent lfn nail-ex had the golden knob locking cam separated from the rest of the device and missing the internal spring, the assembling issues are most likely due to this condition.A dimensional inspection for the aiming arm for adolescent lfn nail-ex was unable to be performed due to dimensions not being applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 aiming arm for adolescent lfn nail-ex 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 the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -aiming arm adolescent lateral entry femoral nail rev f current and manufactured.Dimensional inspection: n/a.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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