MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REV FEM BROACH M-L 35; BROACHES

Catalog Number 251101103

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 02/22/2019

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 during a total knee revision, the surgeon was broaching up to the desired femoral broach size when he was not able to extract the 35mm broach.When the surgeon attempted to remove the broach during a hit with the mallet the broach handle would disconnect from the broach.At that point, the surgeon used the second broach handle in the set when he got the same result as before.Hitting the broach with the mallet during extraction of the 35mm broach would caused it the broach handle to disengaged leaving the broach in the patient.Unable to remove the broach with the broach handles the 1-3 broach adapter was threaded onto the broach then used as a hitting surface for the mallet to get the broach out.As a result the 3-1 broach adapter needs to be replaced because it was bent from removing the 35mm broach.No pieces of the instruments broke off during the procedure, therefore, no pieces had to be retrieved.All parts are being sent back to depuy.

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.Product complaint #: (b)(4).Investigation summary: the device was reviewed by bioengineering and confirmed it was unlikely that a manufacturing defect was present.Root cause undetermined.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 will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE REV FEM BROACH M-L 35
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8400018
• MDR Text Key: 138123154
• Report Number: 1818910-2019-86732
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295437956
• UDI-Public: 10603295437956
• 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,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 251101103
• Device Lot Number: PG274317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR