MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ASSY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112230
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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 or Problem Description
Array clamp and array broke when tightening.Case type: tha.Surgical delay: 2 minutes.Update: "patient was under anesthesia, it happened intra op.No parts of the device were missing before this happened.".
Event or Problem Description
Array clamp and array broke when tightening.Case type: tha.Surgical delay: 2 minutes.Update: "patient was under anesthesia, it happened intra op.No parts of the device were missing before this happened.".
Additional Manufacturer Narrative
Array clamp and array broke when tightening.Case type: tha.Surgical delay: 2 minutes update: "patient was under anesthesia, it happened intra op.No parts of the device were missing before this happened." product evaluation and results: visual inspection : as the product was not returned, therefore an evaluation was not able to be completed.The provided image does not provide enough clarity to determine failure mode, see attachment for provided image.Product history review: product history review was not conducted as lot number provided was incorrect.Complaint history review: complaint history review was not conducted as lot number provided was incorrect.Conclusions: as the product was not returned, therefore an evaluation was not able to be completed, and the failure could not be confirmed.If device and/or additional information become available, this investigation will be reopened.

• Brand Name: PELVIC ARRAY ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8878867
• Report Number: 3005985723-2019-00583
• Device Sequence Number: 227494
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 112230
• Device Lot Number: 1903117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization