MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE TIBIAL TRIAL EXTRACTOR; ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 254500138

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 04/20/2018

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

During a tka the surgeon was sizing poly liners.As the surgeon was lifting the tibial poly extractor the right edge of the extractor broke off hitting the floor.The broken piece was not returned when it reached spd.Patient consequence? :no.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary examination of the returned device confirms the reported event.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.

Manufacturer Narrative

• Brand Name: ATTUNE TIBIAL TRIAL EXTRACTOR
• Type of Device: ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7529508
• MDR Text Key: 108749072
• Report Number: 1818910-2018-60082
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295131021
• UDI-Public: 10603295131021
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/20/2018

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: 254500138
• Device Lot Number: BFA0V4F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 05/29/2018
• Supplement Dates FDA Received: 05/30/2018; 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1