MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE FB TIBIAL IMPACTOR; KNEE INSTRUMENT/TRIAL

Catalog Number 254401003

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 05/26/2017

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

It was reported that the attune impactor was broken during impaction.

Manufacturer Narrative

It was reported that the attune impactor was broken during impaction.The reported event has been evaluated and will be monitored.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

(b)(4).The reported event has been evaluated and will be monitored.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.

Event Description

Complaint description: it was reported that the attune impactor was broken during impaction.

• Brand Name: ATTUNE FB TIBIAL IMPACTOR
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN ; SA ; 5743725905
• MDR Report Key: 6918177
• MDR Text Key: 88455617
• Report Number: 1818910-2017-25969
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130192
• UDI-Public: 10603295130192
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401003
• Device Lot Number: AU4680481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2013
• 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