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Model Number BONE REDUCTION FORCEPS, CURVED, POINTED |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-8943-07, batch 6671651 was received for investigation.Visual inspection identified that both of the tips at the distal end of the forceps had broken.Heavy corrosion was present across the device.The observed condition is consistent with wear and tear damage based on the age of the device.
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Event Description
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It was reported the ar-8943-24 weber clamp, the tip are very bent or broken off.Additional information 8/3/2021 per the sales rep, these devices were actually not used in the case, they had alternative tray options, as shown in the images attached, the tips on the clamps are either dull, bent, or broken off, making them unusable.
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Search Alerts/Recalls
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