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 Consequences Or Impact To Patient (2199)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The blue plastic tip of the tibial impactor broke during impaction of the tibial implant.The tip broke into two pieces, and one of the pieces had to be located inside the patient¿s knee and removed.There was no patient harm.The blue plastic tip does need to be replaced.

Manufacturer Narrative

An event regarding crack/fracture involving a mako impactor was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in used condition.The impactor broke into two pieces.Examination of the returned device with material analysis engineer indicated the trial fractured due to an overload condition.Medical records received and evaluation: not performed as medical records were not received and patient factors didn't contribute to the event.Device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per material analysis performed on the returned device which concluded that the trial was fractured and it was fractured in overload.No further investigation for this event is possible at this time.If additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

The blue plastic tip of the tibial impactor broke during impaction of the tibial implant.The tip broke into two pieces, and one of the pieces had to be located inside the patient¿s knee and removed.There was no patient harm.The blue plastic tip does need to be replaced.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6661450
• MDR Text Key: 78381188
• Report Number: 3005985723-2017-00265
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• 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: 12110814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 99