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

Model Number	304-22-07
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem 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.
Additional 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
• Common Device Name: 6.5MM PLATFORM FX STEM RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10540435
• Report Number: 1038671-2020-00517
• Device Sequence Number: 19635497
• Product Code: KWT
• UDI-Device Identifier: 10885862083388
• UDI-Public: 10885862083388
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 304-22-07
• Device Catalogue Number: 304-22-07
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR