SYNTHES GMBH 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
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Catalog Number 441.901S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); Malunion of Bone (4529)
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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.Initial 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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Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the surgical neck fracture with the proximal humeral plate in question.The surgery was completed successfully.After the surgery, the patient visited the hospital for following up on (b)(6) 2021, and the surgeon checked the x-ray, and there was no problem with the progress.The patient visited the hospital again on (b)(6) 2021 reporting pain.The surgeon found that there was a spiral fracture distal to the plate and the surgical neck fracture was not united; it lost its reduction.The surgeon removed the proximal humeral plate and replaced with another implant on (b)(6) 2021.New implants were fixed with a slight displacement of the diaphysis because the nail diameter is as small as 8 millimeters for the medullary cavity.The surgery was completed successfully without any surgical delay.This report is for a philos plate.This is report 1 of 1 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.H4, h6: a device history record (dhr) review was conducted: part number: 441.901s; lot number: 98p0564; manufacturing site: raron; release to warehouse: 15.April 2021; expiration date: 01.04.2031.A manufacturing record evaluation was performed for the finished device 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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