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

Model Number	112660
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of 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
When inserting the second femoral pin 4x170 it got stuck to the stabilizer.Case type: tka.
Event or Problem Description
When inserting the second femoral pin 4x170 it got stuck to the stabilizer.Case type: tka.
Additional Manufacturer Narrative
Reported issue- when inserting the second femoral pin 4x170 it got stuck to the stabilizer.Product history review ¿ a review of the product history records indicates that (b)(4) were manufactured under catalog #112660 lot no 19020915, and all were accepted into final stock on 8/22/2016.There were no non-conformities identified during inspection.A review of the product history records indicates that (b)(4) were manufactured under catalog #112660 lot no 19020915, and all were accepted into final stock on 10/13/2016.There were no non-conformities identified during inspection.A review of the product history records indicates that (b)(4) were manufactured under catalog #112660 lot no 19020915, and all were accepted into final stock on 8/8/2017.There were no non-conformities identified during inspection.Complaint history review ¿ a review of complaints in catsweb and trackwise related to p/n 112660, lot number 19020915 shows 14 additional complaints related to the failure in this investigation.The complaint (b)(4).Nc/capa history 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.Conclusion ¿ the event was not confirmed as alleged.

• Brand Name: ARRAY STABILIZER, LONG, 4.0MM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9765064
• Report Number: 3005985723-2020-00117
• Device Sequence Number: 504669
• Product Code: OLO
• UDI-Device Identifier: 00848486017880
• UDI-Public: 00848486017880
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• 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): 03/12/2020

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: 112660
• Device Catalogue Number: 112660
• Device Lot Number: 19020915
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/22/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/12/2020
• 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