MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 1; BROACHES

Catalog Number 201001010

Device Problems Naturally Worn (2988); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Examination of the returned broach found the teeth exhibited light wear.Circular scratching was found on the post of the broach.The root cause is attributed to wear and tear from normal use and servicing.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.

Event Description

It was reported that the broaches are showing signs of wear.No 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).Examination of the returned instrument confirmed the complaint.Examination of the returned broach found the teeth exhibited light wear.Circular scratching was found on the post of the broach.The root cause is attributed to wear and tear from normal use and servicing.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 1
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9329788
• MDR Text Key: 186725345
• Report Number: 1818910-2019-116494
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393634
• UDI-Public: 10603295393634
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201001010
• Device Lot Number: PG257838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR