MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MIDDLE SEGMENT TRIAL 25

Catalog Number	309-10-25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
As reported, the trial broke during use in surgery.One of the flanges broke off during the trial process.There was no surgical delay or prolongation and no parts or pieces that fell into the patient¿s wound.The product is available for return.Patient was last known to be in stable condition following the event.After new information was received from the engineers during their investigation, this device has been determined to be reportable due to the nature of the breakage.
Additional Manufacturer Narrative
Section h10: h3: the broken instrument reported was likely the result of not considering specific performance requirements to capture user needs and design inputs (material durability during reprocessing/sterilization as well as for applied over lifetime of device), which led to insufficient testing to demonstrate continued performance over time and resulted in fracture during surgical use.

• Brand Name: EQUINOXE
• Common Device Name: MIDDLE SEGMENT TRIAL 25
• 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: 13479852
• Report Number: 1038671-2022-00181
• Device Sequence Number: 5349141
• Product Code: LXH
• UDI-Device Identifier: 10885862267719
• UDI-Public: 10885862267719
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 309-10-25
• Device Lot Number: 124859003
• 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: 01/18/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/01/2022
• 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 Sex: Unknown