MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MES SIZING/ROT GDE; ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS

Model Number 2544-00-525

Device Problem Material Integrity Problem (2978)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, when the product was inspected by an agent before delivery to the hospital, a possibility of damage was confirmed.Another product was delivered to the hospital.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the photo investigation and visual examination of the returned device found breakage of the center slide component, confirming the reported allegation.All pieces were returned.Additionally, on the black radel around one of the metal bushings the device can be seen chipped.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE MES SIZING/ROT GDE
• Type of Device: ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15137904
• MDR Text Key: 304694661
• Report Number: 1818910-2022-14541
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295434061
• UDI-Public: 10603295434061
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/01/2022

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: 2544-00-525
• Device Catalogue Number: 254400525
• Device Lot Number: AB3729165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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