MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-8MM; IMPLANT

Catalog Number 180705-1

Device Problems Break (1069); Difficult to Insert (1316); Mechanical Problem (1384); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

Tibial insert was damaged while surgeon was trying to seat it.A second insert was opened and implanted.Case was successful and no unusual circumstances were experienced.

Manufacturer Narrative

An event regarding damaged insert due to seating issue involving a mako insert was reported.The event was confirmed.Method & results: device evaluation: visual inspection confirmed the insert was damaged due to implantation.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been 2 other events for the lot referenced.Conclusion: the investigation confirmed that the device was damaged during attempt at implantation.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

Tibial insert was damaged while surgeon was trying to seat it.A second insert was opened and implanted.Case was successful and no unusual circumstances were experienced.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 5-8MM
• Type of Device: IMPLANT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4922954
• MDR Text Key: 22457310
• Report Number: 3005985723-2015-00127
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Report Date: 06/22/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 180705-1
• Device Lot Number: 12340215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other