MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; STEREOTAXIC DEVICE, ROBOTICS

Model Number	111653
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
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
Acetabulum checkpoint broke off upon removal.Piece was removed from hip using midas burr.Case type: tha.Surgical delay: = 15 minutes.
Event or Problem Description
Acetabulum checkpoint broke off upon removal.Piece was removed from hip using midas burr.Case type: tha.Surgical delay: = 15 minutes.
Additional Manufacturer Narrative
Reported event: acetabulum checkpoint broke off upon removal.Piece was removed from hip using midas burr.Case type: tha, surgical delay: = 15 minutes.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 cannot be conducted as the lot number is not provided.Complaint history review: review of the complaint history records cannot be conducted as the lot number is not provided.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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that there have been no nc¿s associated with the product and failure mode reported in this event.

• Brand Name: CHECKPOINT, 3.5 HEX IMPACTION STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9602191
• Report Number: 3005985723-2020-00044
• Device Sequence Number: 16693576
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/11/2020

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 Model Number: 111653
• Device Catalogue Number: 111653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 03/11/2020
• 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: Other
• Patient Age: 62 YR
• Patient Weight: 72