MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIV REV FEM BROACH REAMER; KNEE INSTRUMENT : BROACHES

Catalog Number	961671
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision tkr, (b)(6) hospital (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.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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: UNIV REV FEM BROACH REAMER
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7519655
• Report Number: 1818910-2018-59789
• Device Sequence Number: 11265551
• Product Code: HTQ
• UDI-Device Identifier: 10603295239772
• UDI-Public: 10603295239772
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 961671
• Device Lot Number: B0807
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/28/2018; 11/29/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/07/2018; 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1