MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/0; IMPLANT

Catalog Number 6570-0-136

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

The customer reported via the sales rep that they opened the device during surgery and noticed that the second inner blister pack was missing.The customer reported that another identical device was immediately available to complete the surgery successfully and therefore there were no adverse consequences or delays.

Manufacturer Narrative

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

Manufacturer Narrative

There were no reported discrepancies and there were no other events for the referenced lot.Visual inspection was performed on the returned packaging.The device, inner blister, outer blister and outer packaging were returned.The outer tyvek had been peeled back on 3 sides of the outer blister.There was no inner tyvek and no inner tyvek seal was present on the inner blister, indicating that no inner tyvek had ever been present.No medical record evaluation performed that would not be of value to the investigation and no adverse consequences to the patient were reported.A non conformance was raised to further investigate the issue.Product surveillance will continue to monitor for trends.The reported event regarding a packaging issue involving a delta v-40 ceramic head 36/0 was confirmed.

Event Description

The customer reported via the sales rep that they opened the device during surgery and noticed that the second inner blister pack was missing.The customer reported that another identical device was immediately available to complete the surgery successfully and therefore there were no adverse consequences or delays.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/0
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3691957
• MDR Text Key: 16804888
• Report Number: 0002249697-2014-00837
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K052718
• 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: 02/25/2014

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: 01/31/2019
• Device Catalogue Number: 6570-0-136
• Device Lot Number: 46441405
• Other Device ID Number: STER. LOT 1401FC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 03/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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