MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ETS. HIP ENDOPROSTHESIS; IMPLANT

Catalog Number 0590-3-044

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/09/2015

Event Type  malfunction  

Event Description

The sales rep.Has reported via the (b)(6) customer service department, that when the device was opened during surgery, it was noticed that the inner packaging was allegedly damaged and reportedly compromising the product.The sales rep has reported that there is no damage reported to the outer packaging.The sales rep, has further reported that the device looked intact until the nurse peeled back the paper lid to hand the implant onto the sterile field but in doing, so the clear plastic part of the box broke away with it and there were allegedly small fragments, the sterile field was not contaminated and although the inner most sterile box appeared intact the theatre sister was not happy to proceed with that implant just in case the sterility had been compromised.The sales rep has further reported that there was no delay to surgery and that the surgery was completed by using another implant that was immediately available on the shelf.No adverse consequences to the patient and no medical intervention required.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.

Manufacturer Narrative

An event regarding a packaging issue involving an ets.Hip endoprosthesis was reported.The event was confirmed.Method & results: -device evaluation and results: the complete packaging with the device has been returned: carton box, outer and inner blister.The carton box shows an impact mark, on the lateral side.The external blister is broken at an angle.Two pieces of the broken blister are missing.The inner blister is not opened and intact.There is a 100% inspection of the sealed blister after sealing step.Such a defect would have been detected during the packaging steps.The outer blister damage was most likely caused by an impact to the corner of the outer blister, after it was removed from the box.-medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.-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.Conclusions: the investigation concluded that the packaging issue was most likely caused by an impact to the corner of the outer blister, after it was removed from the box.

Event Description

The sales rep.Has reported via (b)(4) customer service department, that when the device was opened during surgery, it was noticed that the inner packaging was allegedly damaged and reportedly compromising the product.The sales rep has reported that there is no damage reported to the outer packaging.The sales rep, has further reported that the device looked intact until the nurse peeled back the paper lid to hand the implant onto the sterile field but in doing so the clear plastic part of the box broke away with it and there were allegedly small fragments, the sterile field was not contaminated and although the inner most sterile box appeared intact the theatre sister was not happy to proceed with that implant just in case the sterility had been compromised.The sales rep has further reported that there was no delay to surgery and that the surgery was completed by using another implant that was immediately available on the shelf.No adverse consequences to the patient and no medical intervention required.

• Brand Name: ETS. HIP ENDOPROSTHESIS
• 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: 4484210
• MDR Text Key: 5564804
• Report Number: 0002249697-2015-00243
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 0590-3-044
• Device Lot Number: G3613851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2013
• 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