MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Model Number 180734-1 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
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Event Description
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Wrong size onlay tibial insert was inserted into patient.I wrongly grabbed a size 4 insert instead of size 5 and showed boxes to nurse before opening, surgeon refused to look at boxes to confirm.This resulted in wrong size being put in patient.Both assistant and surgeon didn¿t pick up the size difference on insertion and proceeded with closing the incision.While assistant stitched up, surgeon unscrubbed & looked at patient stickers realizing wrong sizes on labels.Surgeon rescrubbed & i grabbed correct size which was inserted and wrong one discarded.Surgical delay of 10 minutes to change the insert.
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Event Description
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Wrong size onlay tibial insert was inserted into patient.I wrongly grabbed a size 4 insert instead of size 5 and showed boxes to nurse before opening, surgeon refused to look at boxes to confirm.This resulted in wrong size being put in patient.Both assistant and surgeon didn¿t pick up the size difference on insertion and proceeded with closing the incision.While assistant stitched up, surgeon unscrubbed & looked at patient stickers realizing wrong sizes on labels.Surgeon rescrubbed & i grabbed correct size which was inserted and wrong one discarded.Surgical delay of 10 minutes to change the insert.
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Manufacturer Narrative
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Reported event: an event regarding user error involving a insert was reported.The event was confirmed based in implant sheet.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 21 sept 2020 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: no further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened h3 other text : device not returned.
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Search Alerts/Recalls
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