MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT TRL38MM; ATTUNE INSTRUMENTS : PATELLA TRIALS

Catalog Number 254501028

Device Problem Component Missing (2306)

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: no device associated with this report was received for examination.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

When surgical tech removed the attune trial patella from the tray while setting up for the case she noticed one of the pegs missing from the back of the trial.She alerted the sales rep who opened a second attune patella prep tray and used the same trial from it.The surgery had not started and the patient was not in the room when the broken patella was found in the tray.The broken piece was not in the tray.There was no time delay in the case as it happened prior to the patient being brought into the room.

• Brand Name: ATTUNE MEDIAL DOME PAT TRL38MM
• Type of Device: ATTUNE INSTRUMENTS : PATELLA TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 8179185
• MDR Text Key: 130866729
• Report Number: 1818910-2018-78677
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295136057
• UDI-Public: 10603295136057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2018

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: 254501028
• Device Lot Number: MVMBSD890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1