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

Catalog Number 254400525

Device Problems Break (1069); Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2019

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.

Event Description

It was reported that the prop to fix the rotation of the measured sizer (p/n: (b)(4)) was broken when the surgeon attempting to adjust the degree during the tka on (b)(6), 2019, and the spring was come off.The measured sizer was rotated and fixed by 2 person, and 2 pins were inserted for fixation.The surgery was completed, and it was unknown whether there was a surgical delay or not.It was confirmed there was no broken fragment in the patient's body.There was no adverse consequence to the patient.There was no problem when it was checked up the instrument before the surgery so there was a possibility of a fatigue failure may have occurred during sterilization.No further information is available.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: corrected: d10, h3 and h6 product complaint # :(b)(4).Investigation summary
=
> the complaint was confirmed.Due to the age of the product and the assumed number of uses (given the overall condition of the device), a manufacturing defect is not suspected however it is not possible to determine the root cause of this failure.No patient harm was reported.The product shall be retained for future reference device history lot
=
> null.Device history batch
=
> null.Device history review
=
> null.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
• MDR Report Key: 9257757
• MDR Text Key: 184521884
• Report Number: 1818910-2019-113207
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295434061
• UDI-Public: 10603295434061
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254400525
• Device Lot Number: ABE77583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1