MAUDE Adverse Event Report: MAKO SURGICAL CORP. REAMER ATTACHMENT; STEREOTAXIC DEVICE, ROBOTICS

Model Number	204980
Medical Device Problem Codes	Material Fragmentation (1261); Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
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
Event description: the issue was that the reamer and the mics attachment stripped the metal on the back of the straight reamer.Case type: tha.Surgical delay: =15 minutes.
Event or Problem Description
Event description :the issue was that the reamer and the mics attachment stripped the metal on the back of the straight reamer.Case type: tha.Surgical delay: =15 minutes.
Additional Manufacturer Narrative
It was reported that event description :the issue was that the reamer and the mics attachment stripped the metal on the back of the straight reamer.Case type: tha.Surgical delay: =15 minutes.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: 1.Review of the device history records indicate 31 devices were manufactured and accepted into final stock on 06/11/2018 with no reported discrepancies.2.Review of the device history records indicate 03 devices were manufactured and accepted into final stock on 07/14/2018 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 204980, lot 40m068080 shows 1 additional complaints related to the failure in this investigation.Conclusions: 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.

• Brand Name: REAMER ATTACHMENT
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9237975
• Report Number: 3005985723-2019-00760
• Device Sequence Number: 13864472
• Product Code: OLO
• UDI-Device Identifier: 00848486021832
• UDI-Public: 00848486021832
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141989
• 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): 02/26/2020

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 Model Number: 204980
• Device Catalogue Number: 204980
• Device Lot Number: 40M068080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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