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

Catalog Number 254401017

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

(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 impaction handle red release switch and spring broke off during surgery.Both pieces retrieved.No surgical delay.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Investigation summary
=
> examination of the returned device confirmed the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint consisted of (1) 254401017 attune impaction handle, lot number nw147397.Examination of the returned device confirmed that the attune impaction handle had a broken lever.All pieces excluding the spring 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 (b)(4) was initiated on (b)(6) 2014 to investigate and determine the root cause of the failure and concluded the root cause as undetermined.A (b)(4) /(b)(4) was initiated on (b)(6) 2014 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- (b)(4).Device history lot
=
> null.Device history batch
=
> null.Device history review
=
> null.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.Corrected: h3.Added:d10.If information is obtained that was not available for the initial 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: 8451942
• MDR Text Key: 139849521
• Report Number: 1818910-2019-88481
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295423324
• UDI-Public: 10603295423324
• Combination Product (y/n): N
• 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: 03/06/2019

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: NW147397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR