MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE IMPACTION HANDLE; ATTUNE INSTRUMENTS : HANDLES

Catalog Number 254401017

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 01/22/2019

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.Evaluation of the returned device revealed a broken locking mechanism.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) 254401017 attune impaction handle, lot number nw147381.Evaluation of the returned device confirmed that the attune impaction handle had a broken lever (locking mechanism).The handle component was not broken.All pieces, except for the spring component, were returned for evaluation.Complaints databases searched on product codes 254401017 identified previous complaints received for this failure mode.With regard to the redesigned handle; significant changes were done to increase the robustness of the lever and prevent the lever from going to a 3 point bend which had resulted in failures of a similar design previously.The device is provided with a hard stop against the attune tibial tower and even in this condition there is room for the lever to rotate further which prevents it from going to a 3 point bend.It is speculated that the device failed during tibial preparation (when used with the tibial tower).The risk of breakage of the lever has been considered in the risk assessment.The potential harms include- soft tissue irritation/ pain/ adverse tissue reaction & surgical delay.The complaint does not indicate any patient effect or surgical delay.The attune kit contains 2 handles for improving surgical efficiency.Both handles are never used simultaneously for a procedure.It should be noted that an investigation was initiated to investigate and determine the root cause of the failure and concluded the root cause as undetermined.A hhe with a recommended field correction in the form of a communication to device users.Further corrective action has been identified and information can be found under capa.Complaint trends will be monitored by post market surveillance through (b)(4).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

Lever broke from the impactor handle and femoral trial broke into two separate pieces.The anterior flange broke off of the trial.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: evaluation of the returned device revealed a broken locking mechanism.Depuy synthese 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 IMPACTION HANDLE
• Type of Device: ATTUNE INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8339640
• MDR Text Key: 136166992
• Report Number: 1818910-2019-84590
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295423324
• UDI-Public: 10603295423324
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

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 Catalogue Number: 254401017
• Device Lot Number: NW147381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1