MAUDE Adverse Event Report: MAKO SURGICAL CORP. SHELL IMPACTION PLATFORM; STEREOTAXIC DEVICE, ROBOTICS

Model Number	206270
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
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
Prong on impaction platform broke.Case type: tha.
Event or Problem Description
Prong on impaction platform broke.Case type: tha.
Additional Manufacturer Narrative
It was reported that "prong on impaction platform broke." method & results: -device evaluation and results: not performed as no items were returned.-product history review: the reported lot number appears invalid; the review is performed with similar lot number: 45010418.Review of the device history records indicates (b)(4) device(s) were manufactured and accepted into final stock on 05/11/18 and (b)(4) device(s) were rejected.Review of qt18-05-0039 indicates the following: (b)(4) device(s) were quarantined due to fit check and documentation discrepancies; a quarantine disposition was reported as re-inspect.-complaint history review: the reported lot number appears invalid; the review is performed with similar lot number: 45010418.A review of complaints in catsweb and trackwise related to p/n 206270, lot 45010418 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the exact cause of the event could not be determined because the product was not received.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics or investigator.If devices and / or additional information become available, this investigation will be reopened.

• Brand Name: SHELL IMPACTION PLATFORM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9327525
• Report Number: 3005985723-2019-00804
• Device Sequence Number: 2498208
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/27/2020

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: 206270
• Device Catalogue Number: 206270
• Device Lot Number: 45010148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/29/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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