MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 160177

Device Problems Break (1069); Fracture (1260)

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

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

One tibial insert trial and one tibial impactor was broken during use at the (b)(6) hospital in (b)(6).All broken pieces were removed and taken out of the trays and have been sent for sterilization prior to being shipped back to stryker.The procedure continued as normal.

Event Description

One tibial insert trial and one tibial impactor was broken during use at the nuffield hospital in exeter.All broken pieces were removed and taken out of the trays and have been sent for sterilization prior to being shipped back to stryker.The procedure continued as normal.

Manufacturer Narrative

An event regarding crack/fracture involving a mako impactor was reported.The event was confirmed through inspection by the material analysis engineer.One tibial impactor with lot code 19471216 was returned for evaluation.The blue "foot" has broken off the impactor.Damage is visible on the foot, a section of the foot has broken away.The material analysis engineer indicated: damage consistent with contact against a hard object was observed on the impactor.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No medical records were received for review with a clinical consultant.Indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was reported that the trial insert broke during use.The damaged device was returned for evaluation.Visual inspection of the returned device indicates the blue "foot" has broken off the impactor.Damage is visible on the foot, a section of the foot has broken away.The material analysis engineer indicated: damage consistent with contact against a hard object was observed on the impactor.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7853176
• MDR Text Key: 119498508
• Report Number: 3005985723-2018-00524
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160177
• Device Lot Number: 19471216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other