MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
|
Back to Search Results |
|
Catalog Number 111140 |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/29/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Review of the device history records indicates devices were manufactured and accepted into final stock between with no reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding damage.Lot id: there have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
|
|
Event Description
|
While surgeon was removing femoral trial from patient, tip of slap hammer broke off and got stuck inside the trial.Case type: pka.Update 08/february/2019: rep confirmed surgical delay of 30 seconds.
|
|
Event Description
|
While surgeon was removing femoral trial from patient, tip of slap hammer broke off and got stuck inside the trial.Case type: pka.Update 08/february/2019: rep confirmed surgical delay of 30 seconds.
|
|
Manufacturer Narrative
|
An event regarding crack/fracture involving a femoral trial slaphammer was reported.The event was confirmed by inspection of the returned device.Method & results: product evaluation and results: visual inspection of the returned device noted that burnishing was observed on the tip.Material analysis of the device concluded that the tip of a slaphammer had fractured in the threaded hole of the trial.Intergranular fracture and mixedmode and morphologies were observed on the slaphammer, consistent with an overload condition.The intergranular fracture morphologies are potentially due to hydrogen embrittlement.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: not performed as medical records were not provided for review.Product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that the tip of slap hammer broke off and got stuck inside the trial.Visual inspection of the returned device noted that burnishing was observed on the tip.Material analysis concluded that the tip of a slaphammer had fractured in the threaded hole of the trial.Intergranular fracture and mixedmode and morphologies were observed on the slaphammer, consistent with an overload condition.The intergranular fracture morphologies are potentially due to hydrogen embrittlement.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
|
|
Search Alerts/Recalls
|
|
|