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

Catalog Number 111140

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135); Fracture (1260); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The doctor used the slap hammer to remove the trial the threaded tip broke off in the trial.The threaded tip is stuck in the trial and has not been able to be removed.

Manufacturer Narrative

Device not returned.An event regarding crack/fracture involving a femoral trial slaphammer was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-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 has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Not available.

Event Description

The doctor used the slap hammer to remove the trial the threaded tip broke off in the trial.The threaded tip is stuck in the trial and has not been able to be removed.

Manufacturer Narrative

Additional information added to age or date of birth.An event regarding damage involving a femoral trial slaphammer was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in used condition.The tip of the slap hammer broke off and remained inside the femoral trial.Examination of the returned device with material analysis engineer indicated that the device fracture consistent with an overload condition.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the device fractured due to an overload condition.Examination of the returned device with material analysis engineer indicated that the device fracture consistent with an overload condition.

Event Description

The doctor used the slap hammer to remove the trial the threaded tip broke off in the trial.The threaded tip is stuck in the trial and has not been able to be removed.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6088801
• MDR Text Key: 59976858
• Report Number: 3005738134-2016-00003
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided; 08/07/2017
• Supplement Dates FDA Received: 05/17/2017; 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR