MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 8; BROACHES

Model Number 2010-01-080

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 while broaching with varus pressure with kincise/actis on healthy bone, a size 6 broach post bent and became incarcerated in the anterior kincise broach handle.Surgeon elected to move up to an 8 broach.Using the same varus pressure while broaching with kincise, the post on the 8 broach sheared off at the midpoint of the post.The broken broach was extracted from the canal using a vice grip slap hammer.Surgical delay of 8 minutes.

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.

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 instrument confirmed the complaint.Depuy-synthes 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.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: ACTIS BROACH SZ 8
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9632188
• MDR Text Key: 189355694
• Report Number: 1818910-2020-03003
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393702
• UDI-Public: 10603295393702
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• 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: 01/13/2020

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 Model Number: 2010-01-080
• Device Catalogue Number: 201001080
• Device Lot Number: PG276857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 03/11/2020
• Supplement Dates FDA Received: 02/28/2020; 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR