MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 8 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number 2545-00-738

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

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

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: examination of the returned device found that a scratch present on the flange.The investigation attributed the root cause to unintended user error and the need for corrective action was not indicated.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

The instrument was reported for unknown reason.

• Brand Name: ATTUNE PS FEM TRIAL SZ 8 LT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL 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 ; 6107428552
• MDR Report Key: 12165980
• MDR Text Key: 261462140
• Report Number: 1818910-2021-15141
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295134107
• UDI-Public: 10603295134107
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-738
• Device Catalogue Number: 254500738
• Device Lot Number: MVMGJH030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2019
• 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
• Patient Age: 84 YR