ZIMMER MANUFACTURING SWITZERLAND GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 13 MM, 21.5 CM; ZIMMER NATURAL NAIL
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Model Number N/A |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products - medical devices.Cmn femoral nail, ccd 130, left, 13 mm, 21.5 cm, item# 47249321313 , lot# 3096365.Report source - canada.Multiple mdr reports were filled for this event, please see associated reports: 0009613350 -2022 -00462.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that when the sterile package was opened by removing paper peel, it was observed glue and paper residue remained on the inner side of the packaging.The surgery was completed with another the same product with no health consequences and delay.Attempts have been made and no further information has been provided yet.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned.Visual examination of the provided pictures identified evidence of adhesive residue on seal surface of blister.This is considered to be a cosmetic issue with no adverse impact to product sterility.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.The root cause of the reported issue is attributed to adhesive residue remaining on seal surface of blister on removal of tyvek lid.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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