MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CMW MARK III GUN; DEPUY CMW CEMENTING ACCESSORIES : CEMENT DELIVERY DEVICES

Catalog Number 3210003

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint states: ¿customer reports that the cement gun is defective.¿.

Event Description

Customer reports that the cement gun is defective.

Manufacturer Narrative

B)(4).Investigation summary
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> the complaint states: ¿customer reports that the cement gun is defective.¿ 2 guns were returned for investigation, pre-marked by the hospital with ¿3¿ and ¿4¿.Both guns have failed in the same manner ¿ the trigger spring has sheared into 2 and can no longer activate when squeezed/ released (b)(4)).The samples received confirm the complaint description.The lot identification details from the complaint samples confirm that the guns were manufactured in 2012 and have therefore been available for use for over 6 years.The root cause for the failure in this case is wear and tear.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
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> device history reviewed: device history cannot be reviewed as product is manufactured externally.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: CMW MARK III GUN
• Type of Device: DEPUY CMW CEMENTING ACCESSORIES : CEMENT DELIVERY DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY CMW ¿ 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8701381
• MDR Text Key: 148277925
• Report Number: 1818910-2019-96057
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3210003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1