MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 4; TRIAL/INSTRUMENT

Catalog Number 201001040

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

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 size 4 and male end of actis broach would not fit into broach handle.No surgical delay and patient harm reported.

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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 will be filed as appropriate.

• Brand Name: ACTIS BROACH SZ 4
• Type of Device: TRIAL/INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7115615
• MDR Text Key: 94823181
• Report Number: 1818910-2017-51600
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393665
• UDI-Public: 10603295393665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201001040
• Device Lot Number: PG261636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1