MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 6; BROACHES

Catalog Number 201001060

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

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

The size 6 actis broach had the attachment tip break off and is now stuck in the kincise handle.

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.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 will be filed as appropriate.

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.

• Brand Name: ACTIS BROACH SZ 6
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 9349886
• MDR Text Key: 187271922
• Report Number: 1818910-2019-117281
• Device Sequence Number: 1
• Product Code: KWL
• 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: 10/24/2019

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 Catalogue Number: 201001060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/20/2019; 12/20/2019
• Supplement Dates FDA Received: 12/18/2019; 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1