MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 9 RT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Catalog Number 254500729

Device Problems Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported damage.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.The complaint consisted of (1) 254500729 attune ps fem trial sz 9 rt.Examination of the returned device confirms the reported damage.Damage to the lateral aspect of the trial was found which is consistent with saw blades coming in contact with the device.A complaint database search on the provided product code family identified similar reports which when confirmed were attributed to user error.Per surgical technique 0612-10-512 (page 58, care should be taken to avoid saw blade excursion into the femoral trials or implants).The root cause is attributed to inadvertent user error.Based on the root cause of unintended user error, the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through sep-419.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

It was reported that the 9 right attune femoral trial found damaged with saw blade and cannot be resterilized.No surgical delay.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported damage.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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FEM TRIAL SZ 9 RT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9452868
• MDR Text Key: 188063641
• Report Number: 1818910-2019-122484
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295134015
• UDI-Public: 10603295134015
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500729
• Device Lot Number: MVMBSZ390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1