MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION T-HANDLE; KNEE INSTRUMENT : HANDLES

Catalog Number 217863137

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

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.

Event Description

Revision tkr, (b)(6) 2018.When setting up the instruments.Jnj representative noticed that the hudson adapter and the t handle were splade and when test they did not work.Jnj representative tested the drill shaft and broach reamer and there were slots broken.Due to no fault of this, the surgery got cancelled.Jnj representative replaced the instruments for the re-scheduled case.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).This device was not returned for evaluation but photographs were received not confirming the reported event but do show evidence of stripping and wear.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REVISION T-HANDLE
• Type of Device: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7519618
• MDR Text Key: 108490740
• Report Number: 1818910-2018-59787
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295096269
• UDI-Public: 10603295096269
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 217863137
• Device Lot Number: J0709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 05/28/2018; 11/29/2018
• Supplement Dates FDA Received: 06/07/2018; 12/04/2018
• Date Device Manufactured: 07/15/2009
• 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