MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE EM TIBIAL PROX UPROD; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number 254400017

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.Examination of the device showed device white markings are worn and illegible.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

This complaint involves one (1) device.No patient consequences or surgical delays reported.

• Brand Name: ATTUNE EM TIBIAL PROX UPROD
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• 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 ; 6107428552
• MDR Report Key: 12851056
• MDR Text Key: 282109127
• Report Number: 1818910-2021-25888
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2021

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: 254400017
• Device Lot Number: PG234257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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