Catalog Number 26-1221 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Udi - (b)(4).Attempts to obtain additional information are being performed.Upon receipt of new relevant information, a follow-up report will be submitted.Refer to mdr 1226348-2018-10668.
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Event Description
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It was reported that two perforator devices were dull and unable to cut the bone.It stopped cutting while drilling and could not perforated the bone.The product was replaced with another similar one but the same issue occurred with the product.The patient has a thick bone.There was no adverse consequence to the patient and no further information was provided by hospital reported.The products will be returned to your site.
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Manufacturer Narrative
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(b)(4).Two devices were returned for evaluation.The perforators were visually inspected.No anomalies were observed.Functional testing was then performed per the test method.A series of holes were drilled without issue.A review of the manufacturing records found no discrepancies when the devices were released to stock.Based on the results of the investigation, the reported issue could not be confirmed.The devices functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Manufacturer Narrative
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A partial lot number has been provided "x3795".Based on lot naming conventions, it is likely that the lot number is hx3795.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
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Search Alerts/Recalls
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