STRYKER ENDOSCOPY-SAN JOSE PKG, ASSY, TITANIUM INTRALINE ANCHOR, 5.5MM W/NEEDLES; SCREW, FIXATION, BONE
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Model Number 3910-400-055 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that there was foreign material in the sterile packaging.
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Event Description
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It was reported that there was foreign material in the sterile packaging.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: packaging compromised.Probable root cause: process uncontrolled environmental conditions.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Search Alerts/Recalls
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