MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; IMPLANT

Catalog Number 5520-B-400

Device Problem Sticking (1597)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Nurse informed sales rep that part of the plastic package left in the label when package was opened.When the package was opened, one of the edge of the plastic box was stuck to the label.The inner packaging was intact.Customer used the product.Operation time did not get longer.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding packaging damage involving a triathlon baseplate was reported.The event was confirmed.The returned outer blister has the lip of one side fully broken off.No other packaging was returned.Device history review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review determined that there were no similar events reported for the lot.The returned outer blister has the lip of one side fully broken off.No other packaging was returned for analysis.The complaint description states "that part of the plastic package left in the label when package was opened".One side of the blister had the flange/lip broken off and remained attached to the tyvek.The event description refers to the tyvek lid as the label.Inspection of the entire packaging of the product is required to determine the root cause of this event.It devices and/or additional information becomes available, this investigation will be reopened.No further investigation for this event is possible at this time.

Event Description

Nurse informed sales rep that part of the plastic package left in the label when package was opened.When the package was opened, one of the edge of the plastic box was stuck to the label.The inner packaging was intact.Customer used the product.Operation time did not get longer.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3825275
• MDR Text Key: 4451234
• Report Number: 0002249697-2014-01907
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K031729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 5520-B-400
• Device Lot Number: EH9HA
• Other Device ID Number: STERILE LOT R3117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2014
• 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