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

Catalog Number	206967
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2019
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
(b)(6) (mps) reported that: "broken inner mesh that causes an error of 0.5 mm when registering the robot" delay : 10min update: was patient in the operating room at the time of discovery? yes.Was patient under anesthesia? yes.Was surgical procedure completed successfully? yes.Case type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update based on the results of investigation.Report issue: (b)(6) (mps) reported that : ""broken inner mesh that causes an error of 0.5 mm when registering the robot."" delay : 10min.Update: was patient in the o.R.At the time of discovery? yes.Was patient under anesthesia? yes.Was surgical procedure completed successfully? yes.Case type: (b)(4).Product inspection: product was not inspected as the product was not returned for evaluation.Device history review: review of the product history records indicate 50 devices were manufactured under lot 19850618 and 49 were accepted into final stock on 01-26-2019.A review of qt 19-01-0096 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206967, lot number 19850618 shows 3 additional complaints related to the failure in this investigation.Conclusion: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Nc/capa review: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.".
Event or Problem Description
(b)(6) (mps) reported that : "broken inner mesh that causes an error of 0.5 mm when registering the robot" delay: 10min.Update: was patient in the o.R.At the time of discovery? yes.Was patient under anesthesia? yes.Was surgical procedure completed successfully? yes.Case type: (b)(4).

• 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: 8970606
• Report Number: 3005985723-2019-00649
• Device Sequence Number: 10844944
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 1903827
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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
• Patient Age: 50 YR