MAUDE Adverse Event Report: MAKO SURGICAL CORP. OFFSET CUP REAMER HANDLE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	207080
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
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
Screw missing from offset reamer handle.Case type: tha.As per the mps: "no patient involvement".
Additional Manufacturer Narrative
Follow-up #1 and final report submitted."reported issue: it was reported that screw missing from offset reamer handle.Product inspection: the failure mode could not be confirmed because the 207080 offset cup reamer handle was not returned for evaluation.Three communication attempts were made and appropriate information was not received.If device and/or additional information become available, this investigation will be reopened.Device history review: review of the device history records indicate 60 devices were manufactured and accepted into final stock on 11/05/2015.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 207080, lot number: 32031015 shows 4 additional complaints related to the failure in this investigation.The complaints are (b)(4).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 no nc and capa associated with the product and failure mode reported in this event" h3 other text : product was not available for evaluation.
Event or Problem Description
Screw missing from offset reamer handle.Case type: tha.As per the mps: "no patient involvement".

• Brand Name: OFFSET CUP REAMER HANDLE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8898630
• Report Number: 3005985723-2019-00594
• Device Sequence Number: 1658663
• Product Code: OLO
• UDI-Device Identifier: 00848486022198
• UDI-Public: 00848486022198
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 207080
• Device Lot Number: 32031015
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 08/15/2019
• 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