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

Model Number 2010-01-040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/28/2021

Event Type  Injury  

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

It was reported that on (b)(6) 2021, the patient underwent the bha surgery with a actis implant.In the surgery, os calcar femorale was fractured.The event took place in sequence as follows: the reduction was difficult, when the trial reduction after rasping was performed.After reduction, when the surgeon dislocated it again, the calcar part was fractured.The implantation was completed using a nespron cable.The surgery was completed successfully within 30 minutes.The surgeon was commented that the fracture that occurred during surgery was a technical error.No further information is available.Doi: (b)(6) 2021, unknown hip.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will bereviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: ACTIS BROACH SZ 4
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13235644
• MDR Text Key: 283667308
• Report Number: 1818910-2022-00656
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295393665
• UDI-Public: 10603295393665
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2010-01-040
• Device Catalogue Number: 201001040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Female