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

Model Number 111651

Device Problem Fracture (1260)

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

Event Date 11/27/2019

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

Tibia checkpoint tip broke off in patient while extracting.Tip remaining in patient is roughly 2 mm.Case type: tha.Surgical delay: = 15 minutes.

Event Description

Tibia checkpoint tip broke off in patient while extracting.Tip remaining in patient is roughly 2 mm.Case type: tha.Surgical delay: = 15 minutes.

Manufacturer Narrative

Reported event: tibia checkpoint tip broke off in patient while extracting.Tip remaining in patient is roughly 2 mm.Case type: tha.Surgical delay: = 15 minutes.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the product history records indicate 09 devices were manufactured under lot no w60117-1.And accepted into final stock on 01/03/2012.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 w60117-1 shows no additional complaints related to the failure in this investigation.Conclusions: the event was not confirmed as the product was not available for inspection.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.H3 other text : device not returned.

• 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: 9511707
• MDR Text Key: 175876173
• Report Number: 3005985723-2019-00916
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 111651
• Device Catalogue Number: 111651
• Device Lot Number: W60117-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 79