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

Model Number	83-1615
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1818910-2021-25824
• Device Sequence Number: 14656578
• Product Code: KIH
• UDI-Device Identifier: 10603295202493
• UDI-Public: 10603295202493
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 11/21/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTMIX CEMVAC; SMARTMIX CEMVAC; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Patient Sex: Female