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

Catalog Number 111140

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

During trailing the threaded tip of the femoral implant inserter broke off inside the size 6 lm femoral trial.Pka case.

Event Description

During trialing the threaded tip of the femoral implant inserter broke off inside the size 6 lm femoral trial.Pka case.

Manufacturer Narrative

An event regarding crack/fracture involving a femoral trial slaphammer was reported.The event was confirmed through mar.Method & results: device evaluation and results: the mar concluded: the slaphammer tip fractured with the tip remaining in the trial.Mixed-mode and intergranular fracture morphologies were observed on the slaphammer, consistent with an overload condition.The slaphammer met the drawing requirement for hardness.The intergranular fracture morphologies are potentially due to hydrogen embrittlement.Eds showed the slaphammer was consistent with 465 ph stainless steel alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there have been no other similar reported events.Conclusions: the mar concluded: the slaphammer tip fractured with the tip remaining in the trial.Mixed-mode and intergranular fracture morphologies were observed on the slaphammer, consistent with an overload condition.The slaphammer met the drawing requirement for hardness.The intergranular fracture morphologies are potentially due to hydrogen embrittlement.Eds showed the slaphammer was consistent with 465 ph stainless steel alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7582220
• MDR Text Key: 110474797
• Report Number: 3005985723-2018-00344
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486002732
• UDI-Public: 00848486002732
• 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: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• 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: 06060117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other