MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 4 RT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number 2545-00-724

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Not Applicable (3189)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Examination of the returned device confirmed the trial had broken into two pieces.The trial is fractured across the medial condyle.All pieces were returned for evaluation.The device exhibited minimal wear depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

During impaction the lateral condyle of the attune femoral trial broke off (254500724).As the pieces of the broken trial were removed it was found that the patient had developed a non displaced lateral femoral condylar fracture starting at the anterior portion of the box resection and extending to the posterior portion of the femur.This was repaired using two 4.0mm cannulated screws and the surgery was finished with no further incident.

• Brand Name: ATTUNE PS FEM TRIAL SZ 4 RT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• 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: 10309167
• MDR Text Key: 199901243
• Report Number: 1818910-2020-16542
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295133964
• UDI-Public: 10603295133964
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-724
• Device Catalogue Number: 254500724
• Device Lot Number: MVMBWY980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR