MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 4; BROACHES

Model Number 2010-01-040

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/01/2020

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

During the broaching process of an anterior hip, the size 4 actis stem broke at the post and was lodged in the femur.After an hour of trying to remove the stem, the surgeon was finally able to remove the broken broach.Once the broach was removed he then continue on with the case and implanted all implants.Surgical delay of 5 minutes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary examination of the returned instrument confirmed the complaint.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.

• Brand Name: ACTIS BROACH SZ 4
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10694986
• MDR Text Key: 211853207
• Report Number: 1818910-2020-22670
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393665
• UDI-Public: 10603295393665
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2010-01-040
• Device Catalogue Number: 201001040
• Device Lot Number: PG274010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 82