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Model Number 014208 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, when opening a sterile package of "6mm x 30mm screws"'; a size of 6mm x 20mm screw were contained instead of the one of size "6mm x 30mm".No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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G4, h2, h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that four devices of the same batch number were returned.None had been removed from the original packaging.The devices were found to be 6mm x 20mm instead of the specified 6mm x 30mm.A review of the device records found that the reference materials used to create and verify the dimensions of this batch were used incorrectly, leading to incorrect specifications for this work order.A complaint history review concluded this was a repeat issue.A review of the drawing found that the dimensions and specifications for of three products were contained in the same document.This product was specified to be 6mm x 30mm.The complaint was confirmed and the root cause was associated with manufacturing.Corrective actions have been initiated and are in progress to recall the batch from the field.
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Manufacturer Narrative
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Correction in h7 and h9.
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Search Alerts/Recalls
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