MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE GLENOSPHERE

Catalog Number 320-01-38

Device Problems Component Missing (2306); Human-Device Interface Problem (2949)

Patient Problems Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

The glenosphere was implanted with no locking screw.

Event Description

The glenosphere was implanted with no locking screw.The glenosphere got locked on the plate in a skewed orientation and the surgeon couldn't get the locking screw in or the glenosphere out.She chose to proceed without the screw, saying it was "operator error" and "the lesser of two evils" versus repeatedly undermining the plate fixation via usage of the extractor hook.The health care professional inspected the screw and indicated that it looked good to her and declined a new/spare one from the kit.She seemed sure that the skewed connection between the plate and the hemisphere meant that the screw had to go round a corner, so the problem wasn't a crossed thread.Attempt to get the head to go to the safe side of the articulating surface of the glenosphere were unsuccessful.Post-op x-rays provided.Surgeon said she saw the patient at 8 weeks post-op and she is doing brilliantly, no problems at all.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00798, and 1038671-2017-00800.

Manufacturer Narrative

After further review of this complaint, it is determined that this complaint is not reportable.There was no reported harm or serious injury to the patient.The surgeon determined used her knowledge of anatomy, years of experience, and judgement of knowledge of the device to determine it was better to leave the implant in place as was.At 8 weeks postop check the surgeon stated the patient was "doing brilliantly" and there is no historical knowledge (searched 10/2017- 04/2019) of this manufacturer that this device has been revised.The investigation determined: was likely the result of human error as the surgeon was unable to properly seat the glenosphere onto the glenoid plate.However, this cannot be confirmed because the component was not available for evaluation.It is explained in the warnings and precautions of the labeling: warnings and precautions.Only qualified surgeons knowledgeable in anatomy, biomechanics, and reconstructive surgery should use the devices.The surgeon must be fully knowledgeable about all aspects of the equinoxe surgical technique and use these implants in accordance e with the respective indications and contraindications.In addition, the surgeon should be fully knowledgeable about the compatibility of system components and use each device accordingly.Also, the surgeon must be fully knowledgeable about the surgical technique and they must be trained according to the proper use of the system instrumentation.This device is used for treatment not diagnosis.

• Brand Name: EQUINOXE REVERSE GLENOSPHERE
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 6999004
• MDR Text Key: 92090894
• Report Number: 1038671-2017-00799
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR