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Catalog Number 03.043.029 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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It was reported that the device was received as blind unit and couldn¿t be associated with a complaint or any other existing record.On (b)(6) 2023, during manufacturer's preliminary investigation of the returned device it was identified that the device is broken.This report is for one (1) aiming arm/ radiolucent.This is report 1 of 1 for complaint (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.E3: reporter is a j&j employee.H3, h6: the subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H3, h4, h6: 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 aiming arm/ radiolucent had both of the hooks of the latch broken, fragments were not received in the evidence provided.No other issues were found.The device has signs of normal use/wear and no evidence of hammer marks were observed, therefore, a potential cause cannot be established with the provided information due to be a multifactorial issue.The semi-extended parapatellar approach surgical technique guide was reviewed.The following relevant statements were found.Precautions: -ensure that the connection between the nail and the insertion handle is tight.Retighten if necessary, after hammering and prior to the attachment of the aiming arm.-do not attach the aiming arm to the insertion handle at this point.-do not exert forces on the aiming arm.These forces may prevent breakage of the device.Based on the investigation findings, the primary cause was related to the users hammering with the aiming arm in place or actually hitting on the aiming arm.A dimensional inspection for the aiming arm/ radiolucent was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the aiming arm/ radiolucent would contribute to the complained device issue 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): part: 03.043.029, lot: 2029724, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 27 apr 2022, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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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