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

Model Number	206270
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
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
During impaction, the offset impactor broke at the attachment area for the impaction pad.When we tried to put the impaction pad on another impactor it would not fit or lock on.The impactor shaft complaint was recorded in (b)(4).Case type: tha.Surgical delay; x <= 15 minutes.
Event or Problem Description
During impaction, the offset impactor broke at the attachment area for the impaction pad.When we tried to put the impaction pad on another impactor it would not fit or lock on.The impactor shaft complaint was recorded in (b)(4) case type: tha surgical delay; x <= 15 minutes.
Additional Manufacturer Narrative
Reported event: it was reported that during impaction, the offset impactor broke at the attachment area for the impaction pad.When we tried to put the impaction pad on another impactor it would not fit or lock on.The impactor shaft complaint was recorded in (b)(4).Case type: tha.Surgical delay; x <= 15 minutes.Product evaluation and results: (b)(4) could not be completed as the 206270 shell impaction platform was not provided.Three communication attempts were made and appropriate information was not received.Product was not returned.Product history review: review of the device history records indicate (b)(4) devices were manufactured and (b)(4) accepted into final stock on 09/28/2018.Certificate of conformance shows that (b)(4) devices were accepted dated 09/05/2018 and (b)(4) devices were accepted dated 09/06/2018.Review of qt 18-09-0145 revealed that the non conformance is not related to the failure alleged in the event.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206270, lot 45030818 shows 1 additional complaints related to the failure in this investigation.The complaint is (b)(4).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.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: 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: 9378966
• Report Number: 3005985723-2019-00855
• Device Sequence Number: 14017712
• 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): 04/22/2020

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: 45030818
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 04/22/2020
• 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