MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® SHELL IMPACTOR-OFFSET-REST-PST; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 209360

Device Problems Sticking (1597); Failure to Disconnect (2541); Insufficient Information (3190)

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

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After impacting the acetabular shell with mako robotic assistance , surgeon attempted to detach the impactor shaft from the seated shell in standard fashion using the unscrewing knob on the offset impactor.The knob would not turn.With great difficulty and requiring the use of a femoral canal finger placed into the hole on the unscrewing knob, surgeon was able to unscrew impactor shaft from acetabular shell.Added approximately 3 minutes to procedure.Squeaking was heard as the impactor slowly unthreaded.Case proceeded normally.Impactor shaft isolated and removed from service for inspection and replacement.

Manufacturer Narrative

The device was not returned.The pst offset impactor was difficult to remove from the implant cup.The surgeon was able to remove the impactor from the cup but there was a three minute delay.There was no other harm reported.Device evaluation and results: the product was unavailable for inspection as the product was not returned.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock per a use as is disposition.A review of npr (b)(4) revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints shows zero additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Not returned to manufacturer.

Event Description

After impacting the acetabular shell with mako robotic assistance , surgeon attempted to detach the impactor shaft from the seated shell in standard fashion using the unscrewing knob on the offset impactor.The knob would not turn.With great difficulty and requiring the use of a femoral canal finger placed into the hole on the unscrewing knob, surgeon was able to unscrew impactor shaft from acetabular shell.Added approximately 3 minutes to procedure.Squeaking was heard as the impactor slowly unthreaded.Case proceeded normally.Impactor shaft isolated and removed from service for inspection and replacement.

• Brand Name: RIO® SHELL IMPACTOR-OFFSET-REST-PST
• Type of Device: ORTHOPEDIC STEREOTAXIC 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5300321
• MDR Text Key: 34277320
• Report Number: 3005985723-2015-00300
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209360
• Device Lot Number: 029479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• 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
• Patient Age: 70 YR