MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH FEMORAL TRIAL STD LM/RL SIZE 6; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 170506

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.

Event Description

The threads on the sz6 lm/rl femur trial are cross threaded and won't go on the femur inserter.

Manufacturer Narrative

An event regarding thread damage regarding a mako trial was reported.Conclusion: it was reported that femur trial are cross threaded and won't go on the femur inserter.A visual inspection of the returned trial noted that the first thread was observed to be damaged.Furthermore, a material analysis engineer indicated that damage observed consistent with cross-threading.The device was discovered prior to surgery.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.

Event Description

The threads on the sz6 lm/rl femur trial are cross threaded and won't go on the femur inserter.

• Brand Name: FEMORAL TRIAL STD LM/RL SIZE 6
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6691359
• MDR Text Key: 79280061
• Report Number: 3005985723-2017-00283
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

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 Catalogue Number: 170506
• Device Lot Number: 26220912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 08/23/2017
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2013
• 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