MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE BALANCED FEMORAL SIZER; ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS

Catalog Number 254400517

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem Not Applicable (3189)

Event Date 10/30/2018

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 there was cross threading.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device was returned.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 necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, will be filed as appropriate.

• Brand Name: ATTUNE BALANCED FEMORAL SIZER
• Type of Device: ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 8112380
• MDR Text Key: 128726689
• Report Number: 1818910-2018-76547
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295327554
• UDI-Public: 10603295327554
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

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: 254400517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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