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Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).This report is for an unk - plates: fns/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 that on (b)(6) 2021, the patient underwent for revision surgery of total hip arthroplasty.In the revision surgery, when the surgeon turned the screwdriver to remove a screw, the tip of the screwdriver broke and remained on the screw head.The surgeon tried to pull out the screw with the plate, but it did not move.While hammering, the broken screwdriver tip came off the screw head.The revision surgery was completed successfully within 30 minutes delay.No further information is available.This complaint involves three (3) devices.This report is for (1) unk - plates: fns.This report is 3 of 3 for (b)(4).Related product complaint: (b)(4).
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Search Alerts/Recalls
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