MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS STD NK SZ4/5; FEMORAL STEM TRIALS

Model Number	2010-02-300
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
While doing a trial reduction with a size 4 actis broach, the trial neck wouldn¿t seat on broach trunnion so the doctor used a mallet to seat trial neck.To remove trial neck the doctor had to use an osteotome.No pieces of the instruments broke during the procedure.
Additional 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.Corrected: h3.

• Brand Name: ACTIS STD NK SZ4/5
• Common Device Name: FEMORAL STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10975784
• Report Number: 1818910-2020-26568
• Device Sequence Number: 11835999
• Product Code: HWT
• UDI-Device Identifier: 10603295393788
• UDI-Public: 10603295393788
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2010-02-300
• Device Catalogue Number: 201002300
• Device Lot Number: PG291788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1