MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTMIX CEMVAC; BONE CEMENT : CEMENT DELIVERY DEVICES

Model Number 83-1615

Device Problem Chemical Problem (2893)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Today we mixed a batch of smart set ghv bone cement and the scrub nurse could not push the white pusher into the top of the smartmix cemvac mixing system.When she eventually got it in and mixed the cement it looked looked lumpy instead of smooth.This was not used and we tried again with a new mix.We had the same issue with the white rod in the top of the mixer but the mix looked better.However when we went to use it stayed running and sticky for a longer time than normal (approx 5 minutes) and was noticed that there were small lumps.The surgeon wasn't happy to continue.We then mixed a third batch of cement from a different supplier (cement and mixing system).15 minute surgical delay.Surgery successfully completed.

Manufacturer Narrative

Product complaint # (b)(4).No 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.

• Brand Name: SMARTMIX CEMVAC
• Type of Device: BONE CEMENT : CEMENT DELIVERY DEVICES
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12850112
• MDR Text Key: 285731984
• Report Number: 1818910-2021-25824
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10603295202493
• UDI-Public: 10603295202493
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83-1615
• Device Catalogue Number: 831615
• Device Lot Number: 21030247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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
• Treatment: SMARTMIX CEMVAC; SMARTMIX CEMVAC; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Patient Sex: Female