MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS BROACH SZ 7; BROACHES

Model Number 2010-01-070

Device Problems Material Deformation (2976); Material Twisted/Bent (2981); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

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 male end of broach handle is bent and will not attach to broach handle.No surgical delay noted.

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. .

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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 will be filed as appropriate.

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.  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).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.Added: h6 (patient code).Territory 242 reported that the male end of broach is bent and will not attach to broach handle.No surgical delay.Functional testing with a mating handle confirmed the complaint of bent and broach will not properly attach.Visual analysis found that the broach post is bent.Deep circular scratching is also seen around the post.The complaint sample consisted of (1) (b)(4) actis broach sz 7, lot pg257849.Review of as400 indicated that this device was distributed for use on 8 jun 2016.A search of the complaint database found similar complaints that attributed the root cause to be from misuse.Deep circular scratching 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 sep 419 post market surveillance.

• Brand Name: ACTIS BROACH SZ 7
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9907253
• MDR Text Key: 190655394
• Report Number: 1818910-2020-09783
• 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,Followup,Followup,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2010-01-070
• Device Catalogue Number: 201001070
• Device Lot Number: PG257849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1