SMITH & NEPHEW, INC. US RAIL CLAMP (SUPINE DISTRACTOR SYS); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Model Number 72200636 |
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 03/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: case-2021-00043558-1.
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Event Description
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It was reported that rail clamps box contained 2 pieces with different serial number, but the outer box only displayed 1 piece serial number.Additionally, the original label information was missing.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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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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Search Alerts/Recalls
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