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

Catalog Number 111140

Device Problems Break (1069); Fracture (1260)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate were manufactured and accepted into final stock with no reported discrepancies.There have been 4 other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Tip of slap hammer broke off in trial.

Event Description

Tip of slap hammer broke off in trial.

Manufacturer Narrative

An event regarding fractured tip involving a femoral trial slap hammer was reported.The event was not confirmed.Method & results: device evaluation and results: material, visual, dimensional & functional analysis could not be performed since device was not returned.Medical records received and evaluation: not performed as medical records were not provided for review.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 4 other events for the lot referenced.Conclusions: it was reported that tip of slap hammer broke off in trial during extraction.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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: 7152055
• MDR Text Key: 96234069
• Report Number: 3005985723-2017-00653
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: 06030614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR