MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #3 RM/LL; IMPLANT

Catalog Number 5620-B-302

Device Problem Device Packaging Compromised (2916)

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

Event Date 01/30/2014

Event Type  malfunction  

Event Description

When opened package, inner package popped out and contaminated.Doctor used spare.

Manufacturer Narrative

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

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot visual inspection: the product box, outer blister with its lid, implant stickers, inner blister with its lid, and implant were returned.The inner (b)(6) lid was not stuck to the outer (b)(6) lid but the inner blister foam was partially stuck to the inner lid.The implant was wrapped up and the wrapping was taped shut.Conclusion: the investigation determined the likely root cause is that the foam was stuck to the inner tyvek lid.When opening the inner blister, the foam came out of the package along with the lid, releasing pkr baseplate from the blister.If additional information becomes available, this investigation will be reopened.

Event Description

When opened package, inner package popped out and contaminated.Doctor used spare.

• Brand Name: TRIATHLON PKR BASEPLATE #3 RM/LL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3651374
• MDR Text Key: 4284249
• Report Number: 0002249697-2014-00534
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2014

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: 11/30/2018
• Device Catalogue Number: 5620-B-302
• Device Lot Number: IRENA
• Other Device ID Number: STERILE LOTE# MSHMR23A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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