MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; COMPRESSION SCREW

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/23/2022

Event Type  Injury  

Event Description

As reported, approximately 3 years post op the initial rsta, this (b)(6) male patient was revised due to unknown reasons.Patient does now know when implant broke.The cage of the baseplate and a screw broke in the scapula.Broken implants were removed and revised to a reverse.Patient was last known to be in stable condition following the event.Devices will not be returning.

Manufacturer Narrative

Device evaluated by mfr: pending evaluation.

Manufacturer Narrative

Device evaluated by mfr: pending evaluation.

Event Description

As reported, approximately 3 years post op the initial rsta, this (b)(6) male patient was revised due to unknown reasons.Patient does now know when implant broke.The cage of the baseplate and a screw broke in the scapula.Broken implants were removed and revised to a reverse.Patient was last known to be in stable condition following the event.Devices will not be returning.

Manufacturer Narrative

Section h10: (h3) the revision reported may have been the result of an insufficient fixation of the baseplate on the glenoid, the lack of a/p compression screws to help resist rocking of the implant in those directions, and patient-related conditions, which ultimately led to the fracture of the baseplate cage and inferior compression screw.However, this cannot be confirmed as the devices were not returned for evaluation.

• Brand Name: EQUINOXE
• Type of Device: COMPRESSION SCREW
• 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: 13590309
• MDR Text Key: 286050844
• Report Number: 1038671-2022-00221
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/22/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male