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

Catalog Number 111140

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Tip of femoral impactor broke off inside the hole of the #4 femoral trial.

Manufacturer Narrative

An event regarding crack/fracture involving amako slaphammer was reported.The event was confirmed by product inspection.Method & results: product evaluation and results: material analysis concluded that " the slaphammer tip fractured in overload.Transgranular and mixed-mode fracture morphologies were observed on the slaphammer, consistent with an overload condition.The slaphammer met the drawing requirement for hardness.Eds showed the slaphammer was consistent with 465 ph stainless steel alloy." clinician review: not performed as medical records were not provided for review.Product history review: product history review indicated the products accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the reported event was confirmed by material analysis report.The mar reported concluded that the slaphammer tip fractured in overload.Transgranular and mixed-mode fracture morphologies were observed on the slaphammer, consistent with an overload condition.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Tip of femoral impactor broke off inside the hole of the #4 femoral trial.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7264087
• MDR Text Key: 99945822
• Report Number: 3005985723-2018-00066
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111140
• Device Lot Number: 06060515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other