MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEMORAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Model Number 2544-01-006

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 examination.There is no reported product problem related to this event.However, after physical review of the part, it was observed it as broken part into 2 pieces.Breakage is at the connection feature.Both parts were find in the decontamination bag.Depuy considers the investigation closed.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

The following device was received as blind unit.Product code: 254401006; lot# au3870946.However, it couldn¿t be associated with a complaint or any other existing record.As a result, this product complaint was created to analyze the returned device from (b)(6).This complaint involves one (1) device.

Manufacturer Narrative

Product complaint # (b)(4).Mfr# 1818910-2021-24589 is being retracted since it was found to be a duplicate of mrf# 1818910-2022-02905.Mfr# 1818910-2022-02905 will be kept for investigation purposes.

• Brand Name: ATTUNE FEMORAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• 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: 12770249
• MDR Text Key: 283422069
• Report Number: 1818910-2021-24589
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130222
• UDI-Public: 10603295130222
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-01-006
• Device Catalogue Number: 254401006
• Device Lot Number: AU3870946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• 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