MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO SURGICAL ARM; STERETACTIC DEVICE

Catalog Number 203999

Device Problems Bent (1059); Physical Resistance (2578)

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

Event Date 01/28/2015

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

The surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, it was noticed that the robotic arm was binding during movement.The arm was adjusted and repositioned.The case was successfully completed.

Manufacturer Narrative

Reported event: the reported device is a rio robotic arm, catalog: 203999, serial number (b)(4).The failing part number is a jevin cable guide, catalog 201946.Method & results: device evaluation and results: per gsp 118316, the covers were removed and found the j3 binding was caused by a bend jevin bracket (p/n 201946).Device history review: the dhr for the rio robotic arm was reviewed.The system passed all inspections and was released to the floor.Complaint history review: a review of the catsweb and trackwise complaint databases revealed that there have been 12 other complaints for this issue for other rio system, but none for the referenced serial number.Conclusions: the failure mode was confirmed and attributed to a bent jevin bracket (b)(4).Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.

Event Description

The surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, it was noticed that the robotic arm was binding during movement.The arm was adjusted and repositioned.The case was successfully completed.

• Brand Name: RIO SURGICAL ARM
• Type of Device: STERETACTIC DEVICE
• 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: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5145623
• MDR Text Key: 28501273
• Report Number: 3005985723-2015-00190
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 02/09/2015

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: No Information
• Device Catalogue Number: 203999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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