MAUDE Adverse Event Report: DEPUY CMW 9610921 MINI KAMVAC SUCTION TUBE; CEMENT / CEMENT ACCESSORY

Catalog Number	530010500
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a foreign material was found.This issue was found during incoming inspection.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Additional Manufacturer Narrative
Examination of the returned device and packaging found the product to meet specifications.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MINI KAMVAC SUCTION TUBE
• Common Device Name: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY CMW 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 7014990
• Report Number: 1818910-2017-28531
• Device Sequence Number: 19342065
• Product Code: JOL
• UDI-Device Identifier: 10603295171508
• UDI-Public: 10603295171508
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 530010500
• Device Lot Number: 54424250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 12/14/2017; 12/19/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 12/19/2017; 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1