MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD; IMPLANT

Catalog Number 6260-9-132

Device Problems Difficult to Remove (1528); Packaging Problem (3007)

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

Event Date 02/27/2014

Event Type  malfunction  

Event Description

The sales rep.Reported that the inner packaging of the lfit heads is difficult to get out of the outer packaging.The sales rep reported that the operating room staff are complaining about this difficulty and have reported that they are concerned about sterility.The sales rep.Reported that the pack has to be shaken to remove the inner packaging from the outer packaging.

Manufacturer Narrative

An event regarding a packaging issue involving a 32mm std lfit v40 head was reported.The event was confirmed.No adverse consequences to the patient were reported.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.This event is associated with a known stryker issue when removing the inner blister from the outer blister.The current design has a lift tab at one of the corners of the inner blister for which to pick the unit out from the outer blister, however, this tab can be difficult to grab.The current method of removing the inner blister from the outer has been reviewed with packaging design team.Although a lift tab exists on the current inner blister, a design improvement is currently in progress to improve and address this issue.

Event Description

The sales rep.Reported that the inner packaging of the lift heads is difficult to get out of the outer packaging.The sales rep reported that the operating room staff are complaining about this difficulty and have reported that they are concerned about sterility.The sales rep.Reported that the pack has to be shaken to remove the inner packaging from the outer packaging.

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

• Brand Name: 32MM STD LFIT V40 HEAD
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3699077
• MDR Text Key: 4365423
• Report Number: 0002249697-2014-00891
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K010757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

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: 6260-9-132
• Device Lot Number: 46158102
• Other Device ID Number: STERILE LOT #: K101MCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 03/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2014
• 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