MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® STRAIGHT SHELL IMPACTOR,TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	209820
Medical Device Problem Codes	Mechanical Problem (1384); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
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
After the cup was fully impacted dr.(b)(6) had a lot of difficulty unscrewing the cup from the impaction handle.Upon removal i noticed the threads were damaged causing the cup to cross thread.Case type: tha.Surgical delay: several minutes attempting to unscrew.
Event or Problem Description
After the cup was fully impacted dr.Ali had a lot of difficulty unscrewing the cup from the impaction handle.Upon removal i noticed the threads were damaged causing the cup to cross thread.Case type: (b)(4).Surgical delay: several minutes attempting to unscrew.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: it was reported that after the cup was fully impacted dr.Ali had a lot of difficulty unscrewing the cup from the impaction handle.Upon removal i noticed the threads were damaged causing the cup to cross thread.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 33783 and (b)(4) devices were accepted into final stock on 09/07/2016 and (b)(4) devices were accepted into final stock on 09/14/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209820, lot number 33783 , shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Device not returned.

• Brand Name: RIO® STRAIGHT SHELL IMPACTOR,TRIDENT PST
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8340946
• Report Number: 3005985723-2019-00138
• Device Sequence Number: 1788970
• Product Code: OLO
• UDI-Device Identifier: 00848486030278
• UDI-Public: 00848486030278
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/07/2019

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 Catalogue Number: 209820
• Device Lot Number: 33783
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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