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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2020
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 supplemental report will be submitted when additional information becomes available.
Event or Problem Description
After retrieving checkpoint screw at the pelvis side, it was found that tip of it was chipped.X-ray couldn't find broken piece.After that, broken piece was found in the bone excised by reaming.
Additional Manufacturer Narrative
Update to b2.Reported event: after retrieving checkpoint screw at the pelvis side, it was found that tip of it was chipped.X-ray couldn't find broken piece.After that, broken piece was found in the bone excised by reaming.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 800 devices were manufactured and accepted into final stock on 05/23/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111653, l/n w63703-1 shows no additional complaints related to the failure in this investigation.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.
Event or Problem Description
After retrieving checkpoint screw at the pelvis side, it was found that tip of it was chipped.X-ray couldn't find broken piece.After that, broken piece was found in the bone excised by reaming.

• 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: 9866070
• Report Number: 3005985723-2020-00172
• Device Sequence Number: 596043
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: W63703-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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; Other