MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB CR ARTIC SURF SZ7; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number 2545-00-527

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: "the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

Event Description

It was reported that the spring of the attune fb cr artic surf sz7 popped off.

• Brand Name: ATTUNE FB CR ARTIC SURF SZ7
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL 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 ; 6107428552
• MDR Report Key: 10994382
• MDR Text Key: 221297630
• Report Number: 1818910-2020-26186
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295132677
• UDI-Public: 10603295132677
• 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: 11/16/2020

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 Model Number: 2545-00-527
• Device Catalogue Number: 254500527
• Device Lot Number: MVMBKY460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2013
• 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