MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ADAPTOR ASSY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112240
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
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
Array clamp and array broke when tightening.Case type: tha.Surgical delay: 2 minutes.Update: "patient was under anesthesia, it happened intra op.No parts of the device were missing before this happened.".
Additional Manufacturer Narrative
Reported event: array clamp and array broke when tightening.Case type: tha, surgical delay: 2 minutes update: "patient was under anesthesia, it happened intra op.No parts of the device were missing before this happened." product evaluation and results: visual inspection : could not be completed as the product was not returned for a functional inspection.Product history review: review of the product history records indicate 100 devices were manufactured under lot no 19161016 and accepted into final stock on (b)(6) 2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to (b)(4), lot number 19161016 , shows no additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode could not be confirmed as the product was not returned.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.H3 other text : product was not available for evaluation.
Event or Problem Description
Array clamp and array broke when tightening.Case type: tha.Surgical delay: 2 minutes.Update: "patient was under anesthesia, it happened intra op.No parts of the device were missing before this happened.".

• Brand Name: PELVIC ARRAY ADAPTOR ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8879237
• Report Number: 3005985723-2019-00584
• Device Sequence Number: 2205998
• Product Code: OLO
• UDI-Device Identifier: 00848486002930
• UDI-Public: 00848486002930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/27/2019

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: 112240
• Device Lot Number: 19161016
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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