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 Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

During implant trailing the slap was screwed into 5lm/rl femur.The slap was hit with a mallet, at the same time the threads broke off the slap and were left in the femur trial.Procedure: pka.

Manufacturer Narrative

An event regarding crack/fracture involving a femoral trial slaphammer was reported.The event was confirmed through provided images.Method & results: device evaluation and results: the device was not returned.However, visual inspection of the picture of the device noted that tip of the slaphammer broke off and remained inside the femoral trial.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 03 other events for the lot referenced.Conclusions: the reported event is confirmed through visual inspection of the image provided however, the root cause couldn't be determined because the devices were not returned for evaluation.The image noted that the tip of the slaphammer broke off and remained inside the femoral trial.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

During implant trialing the slap was screwed into 5lm/rl femur.The slap was hit with a mallet, at the same time the threads broke off the slap and were left in the femur trial.Procedure: pka.

• 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: 7334037
• MDR Text Key: 102218633
• Report Number: 3005985723-2018-00174
• 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: 05/23/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 111140
• Device Lot Number: 06061114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other