MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REPLICATOR PLATE 4.5MM O/S

Model Number 300-10-45

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): screw 300-30-14, 256705008 - equinoxe preserve stem 14mm.

Event Description

As reported, while trialing the final humeral head in an initial left tsa during this (b)(6) y/o female, the surgeon realized the replicator plate was tilted too far.He wanted to unscrew the torque screw and readjust the replicator plate angle.The screw was removed, but when the replicator plate was to be removed, it took out the entire stem.It was a 14mm preserve stem that was rotationally stable.Afterwards, in attempt to reuse the same stem, the surgeon tried to remove the replicator plate on the back table.There was no way to remove the replicator after multiple attempts, a variety of methods, and after much surgical time, the replicator plate was deemed irremovable and another 14mm stem, torque screw and replicator plate had to be opened.The patient was not negatively impacted that we know of, but product was wasted.No known adverse events as a result of the surgical delay/prolongation patient was last known to be in stable condition following the event.Device will return.

Manufacturer Narrative

(h3) the jammed devices reported may have been the result of overtightening the torque defining screw while initially attaching the replicator plate to the stem or after positioning the plate dial, which allowed for cold welding of the replicator plate to the preserve stem, and resulted in the inability to separate the two devices.Section h11: the following sections have corrected information: (d4) serial number: (b)(6), expiration date: 02-sep-2025.(d11) concomitant device(s): 300-30-14, 6431638 - equinoxe preserve stem 14mm.(h4) device manufacture date: 05-sep-2020.

• Brand Name: EQUINOXE
• Type of Device: REPLICATOR PLATE 4.5MM O/S
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11497020
• MDR Text Key: 240340578
• Report Number: 1038671-2021-00115
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079398
• UDI-Public: 10885862079398
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-10-45
• Device Catalogue Number: 300-10-45
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 109