Model Number CS-11120-03M |
Device Problem
Shipping Damage or Problem (1570)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
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Event Description
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It was reported that during a surgery on (b)(6) 2022, it was identified that the packaging of the cemented segmental stem was damaged and no longer sealed.Upon opening the box, this malfunction was identified and the device was not used.The surgeon implanted a different segmental stem.No additional information regarding this malfunction has been reported.
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Manufacturer Narrative
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This report is being submitted to include additional information.The investigation is complete.The device was returned for evaluation.The root cause of the broken sterile barrier could not be determined.The device was visually inspected and it was evident that there was sealant residue on both the inner tray and outer tray and tray lids indicating that the trays had both been sealed properly during packaging.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: h3: device evaluated by manufacturer updated to yes.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 10: testing of actual/suspected device.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 171: packaging compromised.H6: investigation conclusions code updated to 4315: cause not established.
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Event Description
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It was reported that during a surgery on (b)(6) 2022, it was identified that the packaging of the cemented segmental stem was damaged and no longer sealed.Upon opening the box, this malfunction was identified and the device was not used.The surgeon implanted a different segmental stem.No additional information regarding this malfunction has been reported.
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Search Alerts/Recalls
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