MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY CLAMP ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112100
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
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
Dr (b)(6) was tightening the femoral array onto the array adaptor and it broke off inside of the pin clamp.Pka.Surgical delay: 5-10 minutes.
Additional Manufacturer Narrative
Reported event: it was reported that dr anderson was tightening the femoral array onto the array adaptor and it broke off inside of the pin clamp.Product evaluation and results: visual inspection visual inspection confirmed thumb screw broke off in clamp.Dimensional inspection dimensional inspection was not completed since visual and functional inspection confirmed thumb screw broke off in clamp.Functional inspection functional inspection confirmed thumb screw broke off in clamp due to overtightening.Product history review: review of the device history records indicate 60 devices were manufactured under lot 19020711 and rejected on (b)(6) 2011.Review of npr - 11 - 11 - 0015 revealed that all units were dispositioned as "accept and move to stock" on (b)(6) 2011.Non conformance is not related to the failure alleged in this complaint complaint history review: a review of complaints in catsweb and trackwise related to p/n 112100, lot number 19020711 shows no additional complaint 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.H3 other text : product was not available for evaluation.
Event or Problem Description
(b)(6) was tightening the femoral array onto the array adaptor and it broke off inside of the pin clamp.Pka.Surgical delay 5-10 minutes.

• Brand Name: ARRAY CLAMP ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8069715
• Report Number: 3005985723-2018-00676
• Device Sequence Number: 13991700
• Product Code: OLO
• UDI-Device Identifier: 00848486002893
• UDI-Public: 00848486002893
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 03/25/2019

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: 112100
• Device Lot Number: 19020711
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 03/25/2019
• 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