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

Model Number	111653
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
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 supplement al report will be submitted when additional information becomes available.
Event or Problem Description
The pelvic checkpoint broke off in the patient when dr.(b)(6) tried to take it out.Dr.(b)(6) elected to leave the broken checkpoint tip in the patient.Surgical delay = 15 minutes.Case type: tha.Right side.
Event or Problem Description
The pelvic checkpoint broke off in the patient when dr.Jerabek tried to take it out.Dr.Jerabek elected to leave the broken checkpoint tip in the patient.Surgical delay = 15 minutes.Case type: tha.Right side.
Additional Manufacturer Narrative
Reported event: the pelvic checkpoint broke off in the patient when the doctor tried to take it out.The doctor elected to leave the broken checkpoint tip in the patient.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 could not be conducted as the lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.Conclusions: the failure mode could not be confirmed 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: 9663274
• Report Number: 3005985723-2020-00073
• Device Sequence Number: 2800533
• 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: 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): 04/07/2020

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: 01/14/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/07/2020
• 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: Hospitalization
• Patient Age: 59 YR
• Patient Weight: 71