SYNTHES GMBH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAILS-STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 04.005.416S |
Device Problem
Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.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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Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent surgery to treat humerus.The patient did not underwent unreasonable rehabilitation, but cut-out progressed as the patient progressed to 1 to 2 weeks after the initial surgery.According to surgeon the postoperative reduction was good.A revision surgery is not planned.No further information is available.This report is for one (1) 4.0mm ti locking screw w/t25 stardrive 26mm f/im nails-ster.This is report 5 of 7 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.H10 additional narrative: h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the provided photo.Visual analysis of the photo revealed was no damage or defects with the lockscr ø4 l26 f/nails tan dblue found on the x-ray provided.Not enough evidence to confirmed the complaint.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 not confirmed for the lockscr ø4 l26 f/nails tan dblue.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.H6: a device history record (dhr) review was conducted: product code: 04.005.416s; lot number: 227p938; manufacturing site: mezzovico; release to warehouse date: 21 jul 2021; expiration date: 01 jul 2031; a manufacturing record evaluation was performed for the sterile lot number, 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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