MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ACTIS BROACH SZ 3; BROACHES

Catalog Number 201001030

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Not Applicable (3189)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4)."iff information s obwatch, a folsow-u medwatch will be filed as appropriate.Llow-up medwatch will be filed as appropriate.".

Event Description

It was reported that the broach connector piece was broke off while impaction.This is the second time at this account and the surgeon wants it to be investigated.There is no way to remove a broach when this piece is broken.This is a patient safety issue and needs to be addressed.There was 5 minutes surgical delay.

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).The device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.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, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received indicating that it was confirmed that the broken piece of the broach was removed from the patient.

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.Added: b5 corrected: h6 (device code) the previous device code (embedded device) is being retracted as it was further identified that the broken piece of the broach was removed from the patient.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ACTIS BROACH SZ 3
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8705570
• MDR Text Key: 152030735
• Report Number: 1818910-2019-96148
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393658
• UDI-Public: 10603295393658
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201001030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1