MAUDE Adverse Event Report: DEPUY SYNTHES FEMORAL IMPACTOR

Catalog Number 950-50-1171

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 07/17/2014

Event Type  Injury  

Event Description

In reviewing a series of joint infections that appeared to be clustered together, we determined that one link for all of these surgical procedures was this device.The manufacturer was contacted, and we determined that we were cleaning and processing this device according to the manufacturer's recommended procedure.Our sterile processing staff noticed the device had a screws that could be removed, however, we were told that they did not need to be removed.We removed the screws and found bio-burden in the device.This was again shared with the manufacturer who said there was no way for this to get out of the device.We have stopped using this device at our facility.We feel this device may have been a causative factor in the joint infections, however, are unable to make a direct link.Same reporter as mw5038492, mw5038494, mw5038495, mw5038496, mw5038497.

• Brand Name: FEMORAL IMPACTOR
• Type of Device: FEMORAL IMPACTOR
• Manufacturer (Section D): DEPUY SYNTHES
• MDR Report Key: 4152582
• MDR Text Key: 21178092
• Report Number: MW5038493
• Device Sequence Number: 2
• Product Code: LXH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950-50-1171
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 96