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

Catalog Number 254500138

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary
=
> examination of the returned device confirms the reported event.Device history lot
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> null.Device history review
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> null.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 the trial extractor fork broke.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.Device history lot: null.Device history lot: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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

• Brand Name: ATTUNE TIBIAL TRIAL EXTRACTOR
• Type of Device: ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7141874
• MDR Text Key: 95796619
• Report Number: 1818910-2017-52437
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295131021
• UDI-Public: 10603295131021
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

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: BFA0NS7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/09/2017; 12/19/2017
• Supplement Dates FDA Received: 01/08/2018; 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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