MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SMARTMIX BOWL; BONE CEMENT : CEMENT DELIVERY DEVICES

Catalog Number 540180000

Device Problems Chemical Problem (2893); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported once that the same issue occurred intraoperatively (it¿s reported as pc-(b)(4)).The multi pressure vacuum pump (p/n: 831401) and the air line (p/n: 3210031) were connected to the smart mix bowl empty (p/n: 540180000) and used for mixing the cement (manufactured by zimmer) during surgery (date of surgery was unknown).It was reported that bubbles were formed in the cement due to inadequate cement stirring.The surgery was completed and there was no adverse consequence to the patient.It was unknown whether there was a surgical delay or not.No further information is available.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 once that the same issue occurred intraoperatively (it?s reported as (b)(4).The multi pressure vacuum pump (p/n: 831401) and the air line (b)(4).Were connected to the smart mix bowl empty(b)(4).And used for mixing the cement (manufactured by zimmer) during surgery (date of surgery was unknown).It was reported that bubbles were formed in the cement due to inadequate cement stirring.The surgery was completed and there was no adverse consequence to the patient.¿ the products were not received for examination.There is not enough information provided in the complaint description to determine the root cause.This investigation cannot comment on the behaviour of competitor cement in combination with the products in this complaint.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.If information is obtained that was not available for the initial 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8444038
• MDR Text Key: 139696657
• Report Number: 1818910-2019-88161
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 540180000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1