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

Catalog Number 254500138

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.On (b)(6) 2018 re-opened upon receipt of the device evaluation of the returned device finds the one of the tips is fractured.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.

Event Description

Several worn instruments require replacement.

• 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 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8213172
• MDR Text Key: 131963768
• Report Number: 1818910-2019-79791
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295131021
• UDI-Public: 10603295131021
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• 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: BFA10MA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1