MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 4; BROACHES

Model Number 2010-01-040

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Mechanical Jam (2983); Scratched Material (3020); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

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 the 4 actis broach did not release from broach handles or kincise adapters.It stuck and would not release.This did not impact the outcome of the surgery or add any additional time.No surgical delay.

Manufacturer Narrative

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.Territory 234 reported that the 4 actis broach does not release from broach handles or kincise adapters.It sticks and will not release.This did not impact the outcome of the surgery or add any additional time.No surgical delay examination of the returned instrument confirmed the complaint; broach post is slightly bent.A functional check with a mating broach handle found the broach to not assemble smoothly with the handle.A kincise adapter was not available for testing.Visual examination found deep circular scratching on the taper preventing from seating correctly/smoothly onto the broach handle.The complaint sample consisted of (1) 201001040- actis broach sz 4, lot pg288684 review of as400 indicated that this device was distributed for use on 27 feb 2019 a search of the complaint database found similar complaints that attributed the root cause to be from misuse.Deep circular scratching and damage to the post is due to the taper not being seated all the way into the broach handle before locking down on the lever locking mechanism of the broach handle.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.

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.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: ACTIS BROACH SZ 4
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9900759
• MDR Text Key: 186169379
• Report Number: 1818910-2020-09654
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393665
• UDI-Public: 10603295393665
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2010-01-040
• Device Catalogue Number: 201001040
• Device Lot Number: PG288684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KINCISE ADAPTERS