MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 170706-1 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Received part number 170706-1 from an order, but it is the wrong item in the packaging.
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Manufacturer Narrative
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Corrected data: this is a reusable instrument and therefore should not have an expiration date (d4).An event regarding product mix involving a mako baseplate trial was reported.The event was confirmed.Method & results: -product evaluation and results: the products were returned with the packaging.Two baseplate trials were returned, catalog 170604 lot 26080916.The trials were in new condition.Both baseplate trials had catalog #170604 on device with package labels for insert trials, catalog 170706-1 lot number 12371116.-medical records received and evaluation: not performed as medical records were not provided for review.-product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: there has been 7 other events for the lot indicated.Conclusions: the investigation confirmed the reported event of a product mix between the trial baseplate and trial insert.Nc was issued on 15-may-2017 for the product mix.The nc determined the root cause of this event was a lack of standard work where personnel did not perform proper line clearance due to a lack of training.
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Event Description
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Received part number 170706-1 from an order, but it is the wrong item in the packaging.
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Search Alerts/Recalls
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