MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FEM TRIAL SZ 7 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Catalog Number 254500737

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

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 confirms the reported event.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) 254500737 attune ps fem trial sz 7 lt, lot number mvmchc690.Examination of the returned device confirms the reported crack.The trial is cracked medially inferior to the color-coded indicator.The overall appearance of the device exhibits discoloration and scuff marks covering surface of the device.Notching of the femoral groove was found which is consistent with saw blades coming into contact with the device.A complaint database search on the provided product code family identified similar reports which when confirmed were attributed to suspected misuse.Per surgical technique (b)(4) (page 58, care should be taken to avoid saw blade excursion into the femoral trials or implants.The root cause is attributed to suspected user technique and/or misuse.The damage suggests the trial was pried or otherwise inappropriately removed during trialing.Based on the determination of suspected user technique and/or misuse as the root cause, the need for corrective action is not indicated.Monitor through (b)(4).Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

It was reported that the trial was cracked upon impaction.No surgical delay.During in-house engineering evaluation, it was determined that the examination of the returned device confirms the reported crack.The trial is cracked medially inferior to the color-coded indicator.The overall appearance of the device exhibits discoloration and scuff marks covering surface of the device.Notching of the femoral groove was found which is consistent with saw blades coming into contact with the device.

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.H10 additional narrative: product complaint # (b)(4).Investigation summary examination of the returned device confirms the reported event.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 7 LT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8440598
• MDR Text Key: 139465693
• Report Number: 1818910-2019-88046
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295134091
• UDI-Public: 10603295134091
• Combination Product (y/n): N
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500737
• Device Lot Number: MVMCHC690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR