TORNIER S.A.S. BLUEPRINT REVERSED GLENOID GUIDE AND GLENOID BONE MODEL MWJ013; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number MWJ004 |
Device Problems
Component Missing (2306); Inaccurate Information (4051)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2023 |
Event Type
malfunction
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Event Description
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It was reported that the wrong psi guide was put into the box.Surgeon had already started the operation and had to proceed without this planned psi.
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not available.
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Manufacturer Narrative
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The reported event could be confirmed based on the information provided by the manufacturing site.A device inspection was not possible since the affected devices were not returned.However, the reported event of mixing-up of psi guides during packaging was confirmed by the manufacturing site based on evidence received from the customer.The surgeon did not receive the psi guide and the bone model ordered for the surgery (lot # 1rvr00yh).He received a guide and a bone model of a different surgery, with a different patient id and case id (lot # 1rvr00th).The devices inside the packaging did not correspond to what was indicated on the packaging label (which contained the information of the devices ordered by the surgeon).Based on investigation, the root cause was attributed to a packaging related issue.The failure was caused by confusion during the packaging process.The devices in question have the same catalog number and have a very similar lot number.This lead to the devices being mixed-up.The devices of lot # 1rvr00th were put inside the packaging intended for devices lot # 1rvr00yh and vice versa.A nc and a capa were initiated to cover this issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that the wrong psi guide was put into the box.Surgeon had already started the operation and had to proceed without this planned psi.
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Search Alerts/Recalls
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