MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; INSTRUMENT

Catalog Number 111140

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/02/2015

Event Type  malfunction  

Event Description

The slaphammer works for trial extraction, but it does not secure the trial in axial rotation, making it difficult to use for trial insertion.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

Conclusion: the investigation concluded that the surgeon was incorrectly trying to use the subject device for insertion.According to the surgical protocol, ref# (b)(4) version revision #02, the device can only be used for extraction and not for insertion.No further investigation for this event is possible at this time.

Event Description

The slaphammer works for trial extraction, but it does not secure the trial in axial rotation, making it difficult to use for trial insertion.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: INSTRUMENT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4871039
• MDR Text Key: 15584758
• Report Number: 3005985723-2015-00116
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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