MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE HUMERAL ADAPTER TRAY

Catalog Number 320-10-00

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Property Issue (3008)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

Event Description

Index surgery: (b)(6) 2013.Non-revision of right shoulder components due to scapular spine fracture, possibly resulting from a fall.This event report was received through clinical data collection activities.

Manufacturer Narrative

There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the trauma experienced when the patient fell.The ifu notes that extreme care in patient handling (e.G., moving patient, changing clothes, etc.,) immediately after surgery is necessary.Excessive activity and trauma affecting joint replacements have been associated with premature failure.This device is used for treatment not diagnosis.No evaluation.

Event Description

It was reported on (b)(6) 2017 the patient is improving and weaning from the brace/abduction pillow.Associated mfrs with this event: 1038671-2017-00176, 1038671-2017-00177, 1038671-2017-00178, 1038671-2017-00179, 1038671-2017-00180, & 1038671-2017-00181.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: HUMERAL ADAPTER TRAY
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6416795
• MDR Text Key: 70316715
• Report Number: 1038671-2017-00178
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2018
• 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): Other
• Patient Age: 77 YR
• Patient Weight: 49