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

Catalog Number 540180000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that it was broken at connection part of a tube and a filter of the smart mix bowl (p/n: 540180000) when a nurse attempted to connect the tube to a foot switch during the tka surgery on (b)(6), 2019.The surgery was completed without a surgical delay and there was no adverse consequence to the patient.No further information is available.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the complaint states: ¿it was reported that it was damaged at connection part of a tube and a filter of the smart mix bowl (p/n: 540180000) when a nurse attempted to connect the tube to a foot switch during the tka surgery on (b)(6) 2019.The surgery was completed without a surgical delay and there was no adverse consequence to the patient.No further information is available.¿ the hospital has returned the product sample for examination as part of this investigation ( ¿(b)(4) photos.Pdf¿).The complaint description describes the breakage happening when the nurse ¿attempted to connect the tube to a foot switch¿.The pattern displayed by the sheared plastic on the filter indicates that some directional force was applied by the user when it was being attached.The examination of the returned sample confirms the complaint description.The inspection criteria for smartmix bowls require that the components are checked ¿for moulding defects such as shorts, flashing, distortion, inclusions, moulded in or surface contamination and surface finish defects¿, making it unlikely that the parts would leave site in a damaged state.Fmea dva-104409-fde has been reviewed and this failure mode is included on lines 360 to 363 and describe a fracture of the carbon filter body and/ or nozzle.In each case, the risk is considered ¿as low as possible¿ and cannot be further mitigated.(b)(4) extract from dva-104409-fde.Pdf.In conclusion, it appears that the filter nozzle broke due to uneven pressure being applied by the user when assembling the device.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as required.Device history lot: device history reviewed: device history is not available for review as product is manufactured externally.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTMIX BOWL
• Type of Device: BONE CEMENT : CEMENT DELIVERY DEVICES
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8945197
• MDR Text Key: 185253918
• Report Number: 1818910-2019-102498
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 540180000
• Device Lot Number: 1903365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1