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

Model Number 309-10-50

Device Problems Break (1069); Material Twisted/Bent (2981); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 167438787
• Report Number: 1038671-2019-00486
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862267726
• UDI-Public: 10885862267726
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24 YR