MAUDE Adverse Event Report: MAKO SURGICAL CORP. SHELL IMPACTION PLATFORM; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	206270
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
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
Impacting block broke during impaction, bending offset impactor in process.Case type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.It was reported that the impacting block broke during impaction, bending offset impactor in process.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Capa has been raised for lost product.If the device is returned then the complaint will be reopened.Product history review: product history review could not be performed as the part information supplied was invalid (45044215).Complaint history review: complaint history review could not be performed as the part information supplied was invalid (45044215).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.H3 other text : device not returned.
Event or Problem Description
Impacting block broke during impaction, bending offset impactor in process.Case type: tha.

• Brand Name: SHELL IMPACTION PLATFORM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8760052
• Report Number: 3005985723-2019-00495
• Device Sequence Number: 1488964
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/26/2019

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: 206270
• Device Lot Number: 45044215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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