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

Catalog Number	321-15-09
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that during surgical use, the depth gage color was fading.It was noticed by the surgeon when drilling the baseplate screw holes for an (b)(6) female patient.There was no delay.Patient was last known to be in stable condition following the event.Device to be returned.
Additional Manufacturer Narrative
(d4) unique identifier (udi) #: (b)(4).(h3) based on historical complaint data and the reported event, 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.The following sections have corrected information: (h1) type of reportable event: malfunction.

• Brand Name: EQUINOXE
• Common Device Name: GLND SCR DEPTH GAGE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13859064
• Report Number: 1038671-2022-00273
• Device Sequence Number: 16470944
• Product Code: LXH
• UDI-Device Identifier: 10885862087430
• UDI-Public: 10885862087430
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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 Catalogue Number: 321-15-09
• Device Lot Number: 117212031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female