MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; IMPLANT

Catalog Number 6260-9-236

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It is reported by the nurse of the hospital, that the sterile packing of the head wasn´t easy to open, because the inside of the cap was bonding at the protectic cover of the head.During unpacking the wrapper was damaged.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding the tyvek lid packaging being adhered to the inner foam packaging involving a v40 cocr lfit head 36mm/+5 was reported.The event was confirmed through photographs received from the event site.Method and results: device evaluation and results: not performed as the packaging material was not returned for evaluation.Photos of the packaging were provided and showed marks of the tyvek lid being adhered to the foam.Medical records received and evaluation: not performed as no medical records were provided as there was no patient involvement or associated procedure reported.Device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies with the product or its packaging.Complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: the investigation concluded that foam packaging being stuck to the inner blister tyvek lid of a triathlon ts baseplate was caused by a known packaging issue.The raised foam during the sealing operation allowed for excessive contact of the sealing tool with the inner lidstock and packaging foam resulting in sealing or melting of the lidstock to the foam.It is related to a void-filling approach to sterile product packaging.Packaging innovation is aware of this, and has issued a memo.Due to the infrequent nature of these complaints and the greater risk that would be presented by an undersized foam, these events will not be addressed through a design change.

Event Description

It is reported by the nurse of the hospital, that the sterile packing of the head wasn't easy to open, because the inside of the cap was bonding at the protective cover of the head.During unpacking the wrapper was damaged.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4372384
• MDR Text Key: 16885537
• Report Number: 0002249697-2014-05052
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MNE8EV
• Other Device ID Number: STERILE LOT# MSHNJ02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2014
• 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