MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY STABILIZER, SHORT, 4.0MM; STEREOTAXIC DEVICE, ROBOTICS

Model Number	112680
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
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
Bone screw stuck in piece.Case type: tka.
Event or Problem Description
Bone screw stuck in piece.Case type: tka.
Additional Manufacturer Narrative
Reported event: bone screw stuck in piece.Method & results: device evaluation and results: visual inspection: visual inspection confirmed the bone pin was stuck in the array stabilizer.Product history review: review of the device history records indicates (b)(4) device(s) were manufactured and accepted into final stock on 01/23/2019 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112680, lot 19180618 shows 01 additional complaint(s) related to the failure in this investigation.Pr id :(b)(4).Conclusion: the failure was confirmed via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: 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.

• Brand Name: ARRAY STABILIZER, SHORT, 4.0MM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9646747
• Report Number: 3005985723-2020-00064
• Device Sequence Number: 19466697
• Product Code: OLO
• UDI-Device Identifier: 00848486017903
• UDI-Public: 00848486017903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 03/26/2020

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: 112680
• Device Catalogue Number: 112680
• Device Lot Number: 19180618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2019
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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: Other
• Patient Age: 71 YR