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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).510k: this report is for an unk - plates: va locking hand system/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for a revision surgery on (b)(6) 2021 due to long screws in third metacarpal left hand, hematoma in surgical wound.During the surgery, surgical wound sutures are removed, the hematoma is drained, the wound is washed, and the third metacarpal is exposed.Osteosynthesis material is exposed, two screws are removed, osteosynthesis is made with two locked screws, one 16 mm and the other 12 mm.It is washed again, hemostasis, the wound is sutured, it is covered with sterile dressings and bandages, a plaster splint is placed again.The surgery was completed successfully.There was no consequence to the patient.This complaint involves three (3) devices.This report is for (1) unk - plates: va locking hand system.This report is 3 of 3 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.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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