SMITH & NEPHEW, INC. EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Model Number 72200675 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that it was found that when the warehouse printed the eur/uk rail clamp (laterl dstrctr sys) label, the outer box information was not consistent with the actual product because there was only one sn number on the outer box information, and there are two sn number on the real object inside.There was no case reported, therefore there was no patient involved.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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H10.During investigation, it was found that outer box was missing small label stickers that contain serial number information of both devices included in the box.As a result, these units received from supplier were not accepted at incoming inspection to add into inventory.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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