MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIP END EFFECTOR, VARIABLE ANGLE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	206967
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
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
Post-impaction surgical team found a piece of metal near the wound and we discovered it had broken off the end effector.Case type: tha.
Event or Problem Description
Post-impaction surgical team found a piece of metal near the wound and we discovered it had broken off the end effector.Case type: tha.
Additional Manufacturer Narrative
Reported event: post-impaction surgical team found a piece of metal near the wound and we discovered it had broken off the end effector.Case type: tha.Device evaluation and results: visual inspection.Visual inspection confirms fractured device.A piece of the 206966 reamer barrel is missing.See attachments for images of instrument.Dimensional inspection: dimensional inspection was not completed as visual inspection clearly shows failure of device.Functional inspection: functional inspection as not completed as visual inspection clearly shows failure of device.Material analysis: material analysis was completed as part of root cause investigation of capa 1450905.Device history review: review of product history records indicate 50 devices were manufactured under lot no 19170418 and accepted into final stock on 9/21/18.No nonconformance's were identified at this time.Complaint history review: review of complaints in catsweb and trackwise related p/n 206967, l/n 19170418 shows 1 additional complaints related to failure in this investigation.(b)(4).Conclusions: alleged failure confirmed.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: HIP END EFFECTOR, VARIABLE ANGLE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8358267
• Report Number: 3005985723-2019-00178
• Device Sequence Number: 19390587
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/06/2019

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: 206967
• Device Lot Number: 1903508
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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