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Model Number 71106365S |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2020 |
Event Type
malfunction
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Event Description
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It was reported that three of the 6.5mm x 165mm can screws ft stainless steel came sterile packaged with incorrect labeling.These screws are partially threaded but are labeled at fully threaded.There was no case involved.
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Manufacturer Narrative
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H3, h6: the associated device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This issue was previously identified and was evaluated through our internal quality hold process.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.Based on this investigation, the need for corrective action is indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
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Manufacturer Narrative
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Corrected data is in the following sections: h6, h7, and h9: the associated device, intended for use in treatment, was not returned for evaluation and the reported event was confirmed.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This issue was previously identified and was evaluated through our internal escalation process.We have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.Based on this investigation, the need for corrective action is indicated.The health hazard evaluation concluded that in the most likely scenario, the package is opened during surgery and contains a partially threaded version instead of a fully threaded version.The issue is detected prior to use, and a comparable back-up device is used.The procedure is completed with no harm to the patient.In the worst case scenario, the package is opened prior to or during surgery and contains a partially threaded version instead of a fully threaded version.The issue is detected prior to use, and an alternative device(s) is used for the surgery.The health hazard evaluation team recommends escalation to field action board to due to the device appearing to be incorrectly labeled as a fully threaded screw.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Manufacturer Narrative
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this issue was previously identified and was evaluated through our internal escalation process.The package is opened during surgery and contains a partially threaded version instead of a fully threaded version.The issue is detected prior to use, and a comparable back-up device is used.The procedure is completed with no harm to the patient.In the worst case scenario, the package is opened prior to or during surgery and contains a partially threaded version instead of a fully threaded version.Therefore, 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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