MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 6.5MM PLATFORM FX STEM RIGHT

Model Number 304-22-07

Device Problem Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, during an implant procedure on this (b)(6) y/o female patient, the surgeon reamed and asked for a 6.5mm r implant.Implant was chosen as r 6.5 platform fx stem (label on box-304-22-07, sn (b)(4)) and opened.The surgeon tried to implant before noticing it was a left (implant labeled- 304-22-07, sn (b)(4)).No back up implant was available within 100 miles.Could not cement smaller.Surgeon gently power reamed up 0.5mm at a time with different reamers to 8.5 and was able to use an 8.5.Patient was last known to be in stable condition following the event.Device to be returned.

Manufacturer Narrative

Section h10: (h3) per (b)(4), based on the facts available at the time of the health hazard evaluation, the preliminary root cause of the issue reported was likely the result of a failure to perform line clearance.The failure to perform line clearance resulted in comingling of product at passivation which affected downstream manufacturing processes.Capa2020-39 was initiated for further address this issue.

• Brand Name: EQUINOXE
• Type of Device: 6.5MM PLATFORM FX STEM RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10540435
• MDR Text Key: 207360497
• Report Number: 1038671-2020-00517
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862083388
• UDI-Public: 10885862083388
• Combination Product (y/n): N
• PMA/PMN Number: K092900
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 304-22-07
• Device Catalogue Number: 304-22-07
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR