MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNIVERSAL DRIVER-ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112340
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
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
Checkpoint driver piece broke.Case type: tha.Update: as per mps: "broke while impacting the checkpoint.One of the little clips that hold the checkpoint broke off".
Event or Problem Description
Checkpoint driver piece broke.Case type: tha.Update: as per mps: "broke while impacting the checkpoint.One of the little clips that hold the checkpoint broke off".
Additional Manufacturer Narrative
Checkpoint driver piece broke.Case type: tha.Update: as per mps: "broke while impacting the checkpoint.One of the little clips that hold the checkpoint broke off".Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 05/10/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112340, lot number 06080318 shows no additional complaints related to the failure in this investigation.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.

• Brand Name: UNIVERSAL DRIVER-ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9079084
• Report Number: 3005985723-2019-00680
• Device Sequence Number: 2452058
• Product Code: OLO
• UDI-Device Identifier: 00848486017460
• UDI-Public: 00848486017460
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/23/2019

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: 112340
• Device Lot Number: 06080318
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 81