MAUDE Adverse Event Report: DEPUY IRELAND 961610 ATTUNE SPACER BLOCK; KNEE INSTRUMENT/TRIAL

Catalog Number 254401014

Device Problem Crack (1135)

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

Event Date 10/16/2017

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 connector cracked.

Manufacturer Narrative

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Additional narrative: product complaint #
=
> (b)(4).Investigation summary
=
> examination of the returned device(s) confirms the reported event.Product problem has not been identified.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

Product complaint #
=
> pc-(b)(4).

• Brand Name: ATTUNE SPACER BLOCK
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork IN ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7024437
• MDR Text Key: 92200412
• Report Number: 1818910-2017-28819
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295395379
• UDI-Public: 10603295395379
• 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,Followup,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401014
• Device Lot Number: BFA0P57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2013
• 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
• Patient Age: 49 YR