MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM+4MM SKIRTLESS V40 HD TRL; INSTRUMENT

Catalog Number 6264-7-226R

Device Problems Break (1069); Contamination of Device Ingredient or Reagent (2901)

Patient Problem Bacterial Infection (1735)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

The customer reported via the sales rep, that sterile services had swabbed the orange o-ring from one of the exeter v40 femoral trial heads and it had tested positive for bacteria.The customer reported that the heads have been re-processed through an automated washer over 600 times.The customer reported that the orange o-ring that was swabbed had broken apart and had black residue on it.No adverse consequences were reported.

Manufacturer Narrative

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

• Brand Name: 26MM+4MM SKIRTLESS V40 HD TRL
• Type of Device: INSTRUMENT
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3608444
• MDR Text Key: 4176784
• Report Number: 0002249697-2014-00320
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6264-7-226R
• Device Lot Number: 9PEMHD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other