MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 7; BROACHES

Catalog Number 201001070

Device Problems Break (1069); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem Not Applicable (3189)

Event Date 11/19/2019

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 during a direct anterior approach on a right total hip replacement, the actis size 7 broach post broke.The broach was then stuck in the femur.Kincise surgical impactor was being used for the procedure.Surgeon suggesting that there is a deficiency with the product.Case delayed by 10 mins.

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: the instrument associated with this report was not returned.The root cause could not be determined.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.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 7
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9452773
• MDR Text Key: 184253052
• Report Number: 1818910-2019-122470
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393696
• UDI-Public: 10603295393696
• 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
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201001070
• Device Lot Number: PG273933
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR