MAUDE Adverse Event Report: ORTHOPAEDICS, INC. 1818910 ATTUNE TIBIAL TRIAL EXTRACTOR; KNEE INSTRUMENT/TRIAL

Catalog Number 254500138

Device Problem Break (1069)

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

Event Date 08/05/2017

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 trial extractor was broken during surgery.

Manufacturer Narrative

Additional narrative: the device associated with this report was not returned for examination.Depuy considers the investigation closed.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

The device associated with this report was not returned for examination.Depuy considers the investigation closed.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 # (b)(4).Investigation summary: examination of the returned device confirms the reported event.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: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6835862
• MDR Text Key: 84339524
• Report Number: 1818910-2017-23864
• 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,Followup
• Report Date: 08/05/2017

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: BFA0NRY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 09/09/2017; 11/07/2017; 01/11/2018
• Supplement Dates FDA Received: 09/13/2017; 11/22/2017; 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• 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: 63 YR