MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 7; BROACHES

Model Number 2010-01-070

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.The root cause is attributed to 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.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.

Event Description

It was reported that the size 7 actis broach was damaged during normal use and needs to be replaces.No surgical delay.

• Brand Name: ACTIS BROACH SZ 7
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9924421
• MDR Text Key: 186561880
• Report Number: 1818910-2020-10201
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393696
• UDI-Public: 10603295393696
• 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: Other
• Type of Report: Initial
• Report Date: 02/04/2020

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 Model Number: 2010-01-070
• Device Catalogue Number: 201001070
• Device Lot Number: PG288690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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
• Patient Age: 69 YR