MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number	111140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8371496
• Report Number: 3005985723-2019-00188
• Device Sequence Number: 1598650
• Product Code: NPJ
• UDI-Device Identifier: 00848486002732
• UDI-Public: 00848486002732
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 111140
• Device Lot Number: 06031217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 59 YR