MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; IMPLANT

Catalog Number 0580-1-442

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/29/2014

Event Type  malfunction  

Event Description

The sales rep.Has reported on behalf of the customer, that during surgery it was noticed that a long, dark hair was sealed half inside the inner packaging of an exeter stem and half outside which has allegedly compromised the sterility of the implant.The sales rep has reported that another stem was immediately available to complete the surgery as they keep multiple levels of stock on their shelves.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding foreign matter involving an exerter stem was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection confirmed a hair was present from the inside of the inner blister to the outside of the external blister, through the sealing flanges.Stryker (b)(4) performed an integrity test (dye penetration) and it was verified that the seal integrity was intact.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.Conclusions: the investigation concluded that a hair was present within the seals of the returned packaging.Lmo was raised by the supplier to investigate further.

Event Description

The sales rep.Has reported on behalf of the customer, that during surgery it was noticed that a long, dark hair was sealed half inside the inner packaging of an exeter stem and half outside which has allegedly compromised the sterility of the implant.The sales rep has reported that another stem was immediately available to complete the surgery as they keep multiple levels of stock on their shelves.

• Brand Name: EXETER V40 STEM 44MM NO 2
• 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: 4281968
• MDR Text Key: 22058785
• Report Number: 0002249697-2014-04390
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K011623
• 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: 10/30/2014

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: 05/31/2019
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G4416006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2014
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• 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