MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Model Number	209830
Medical Device Problem Code	Fracture (1260)
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
End of offset impactor where impactor pad attaches sheered off during impaction.Case type: tha.Surgical delay: 15 minutes.
Event or Problem Description
End of offset impactor where impactor pad attaches sheered off during impaction.Case type: tha.Surgical delay: = 15 minutes.
Additional Manufacturer Narrative
Reported event: it was reported that end of offset impactor where impactor pad attaches sheered off during impaction.Case type: tha.Surgical delay: = 15 minutes.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.As per visual inspection from the images provided in the communication log, the failure of 'end of offset impactor where impactor pad attaches sheered off during impaction' is confirmed.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 03/17/2016 with no reported discrepancies.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 05/07/2016 with no reported discrepancies.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 05/14/2016 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209830, lot 32952 shows 5 additional complaints related to the failure in this investigation.The complaints are pr: (b)(4).Conclusions: the failure is confirmed via visual inspection from the images provided in the communication log.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: RIO®SHELL IMPACT-OFFSET-TRIDENT PST
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9378535
• Report Number: 3005985723-2019-00852
• Device Sequence Number: 3104416
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141989
• 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): 01/30/2020

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: 209830
• Device Catalogue Number: 209830
• Device Lot Number: 32952
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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