MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MIDDLE SEGMENT TRIAL 50

Model Number	309-10-50
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that the surgeon did a trial reduction under tension, heard a cracking noise then noticed the trial had bent at the junction of the 50mm trial length and the proximal body.The discovered the central peg had snapped off and broken.Then went to trial using the definitive implants instead.Surgery progressed after slight delay.The patient was stable was they left the or.The rep was present at the time of the surgery.
Additional Manufacturer Narrative
Section h10: (h3) the broken instrument reported may have been the result of applying a bending moment to the tines of the middle segment trial while attempting to disassemble the device from the mating proximal body trial, resulting in fracturing of the tines of the middle segment trial.*no information provided in the following section(s): a3, a4, a5, b6, d6, d7, d11, g5, g8, h4, h6, h7.
Additional Manufacturer Narrative
Section h11: the following sections have corrected information: (b1) product problem (e.G., defects/malfunctions).(h1) type of reportable event: malfunction.

• Brand Name: EQUINOXE
• Common Device Name: MIDDLE SEGMENT TRIAL 50
• 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: 9162324
• Report Number: 1038671-2019-00486
• Device Sequence Number: 2811655
• Product Code: KWT
• UDI-Device Identifier: 10885862267726
• UDI-Public: 10885862267726
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2023

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 Model Number: 309-10-50
• Device Catalogue Number: 309-10-50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 02/26/2020; 07/05/2023
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 02/27/2020; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 24 YR
• Patient Sex: Unknown