MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLND SCR DEPTH GAGE

Catalog Number	321-15-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, when the surgeon was using the depth gauge at the time of surgery, he noticed that some of the color-coded scale marks of the gauge was missing in the surgical field.3 scale marks of the depth gauge, black, white, and green, were peeled away from the gauge, but only green was found.Because some of the color-coded marks of the gauge made of epoxy resin was peeled away in the surgical field, the surgeon tried to find all of them, but he couldnt do it.The surgery was finally finished leaving some of them in the surgical field.
Additional Manufacturer Narrative
Section h10: (h3) based on historical complaint data and the complaint devices, the cosmetic issue reported was likely the result of paint fading during years of normal processing/handling, which led to the epoxy paint chipping off.

• Brand Name: EQUINOXE
• Common Device Name: GLND SCR DEPTH GAGE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11076065
• Report Number: 1038671-2020-00666
• Device Sequence Number: 19479524
• Product Code: LXH
• UDI-Device Identifier: 10885862087430
• UDI-Public: 10885862087430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 321-15-09
• Device Lot Number: 145105035
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 03/31/2021
• 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