MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +0(STD) V40 TRIAL HEAD; INSTRUMENT

Catalog Number 6264-8-132R

Device Problems Break (1069); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/13/2013

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 (refer to attached images).No adverse consequences were reported.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

• Brand Name: 32MM +0(STD) V40 TRIAL HEAD
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3589081
• MDR Text Key: 15203542
• Report Number: 0002249697-2014-00179
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122853
• 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: 12/13/2013

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 Catalogue Number: 6264-8-132R
• Device Lot Number: SS107475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2010
• 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