MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 111651

Device Problems Output Problem (3005); Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2019

Event Type  malfunction  

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 Description

Tibial check point sheered off when removing. Case type: tha.

Manufacturer Narrative

Follow-up #1 and final report submitted based on the results of investigation. Reported event: tibial check point sheered off when removing. Product evaluation and results: the product was unavailable for inspection as the product was not returned. Product history review: review of the device history records indicate 1795 devices were manufactured and accepted into final stock on 10/08/2018. No non-conformances were identified during inspection. Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111651, l/n w60115-1 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. Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event. Product was not available for evaluation.

Event Description

Tibial check point sheered off when removing. Case type: tha.

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8955801
• Report Number: 3005985723-2019-00636
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (y/n): N
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 111651
• Device Lot Number: W60115-1
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 85 YR
• Patient Outcome(s): Hospitalization