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

Catalog Number 254500138

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/11/2017

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 tibial trial extractor broke during use.

• Brand Name: ATTUNE TIBIAL TRIAL EXTRACTOR
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 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: 6935538
• MDR Text Key: 89638336
• Report Number: 1818910-2017-26266
• 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
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• 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: BFA0V47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2014
• 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: 58 YR