MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV CEM TIB STEM REAMER; ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS

Catalog Number 250620102

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation of the returned device confirms deformation and the inability to assemble.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

It was reported that the reamer and reamer collet became fused together while reaming.

• Brand Name: ATTUNE REV CEM TIB STEM REAMER
• Type of Device: ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS
• 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: 8655486
• MDR Text Key: 146542963
• Report Number: 1818910-2019-94843
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295440550
• UDI-Public: 10603295440550
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 250620102
• Device Lot Number: NG68444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 05/30/2019
• Date Device Manufactured: 12/11/2017
• 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 Outcome(s): Required Intervention
• Patient Weight: 108