MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SMALL SUPERIOR AUGMENT GLENOID PLATE

Catalog Number	320-35-02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the initial right tsa for this (b)(6) female patient, there was a crack in the coracoid noted due to loosening of the coracoid gps tracker.At this point, the last two screws were placed without computer navigation.There was no action taken and the outcome is noted as: continue to update this adverse event until it has been resolved.Currently, there is no updated information in the clinical study database.The case report form indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): 320-36-00 - 36mm humeral liner +0 unconstrained, 320-10-00 - equinoxe reverse tray adapter plate tray +0, 320-31-36 - glenosphere, 36mm, 300-30-06 - equinoxe preserve stem 6mm.
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the surgical event cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the loosening of the coracoid gps tracker.Section h11: *the following sections have corrected information: (d4) catalog number: 320-35-02, unique identifier (udi) #: (b)(4).(g4) pma/510(k)number: k180632.(d10) concomitant device(s): 320-36-00 - 36mm humeral liner +0 unconstrained.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-31-36 - glenosphere, 36mm.300-30-06 - equinoxe preserve stem 6mm.

• Brand Name: EQUINOXE
• Common Device Name: SMALL SUPERIOR AUGMENT GLENOID PLATE
• 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: 14207764
• Report Number: 1038671-2022-00462
• Device Sequence Number: 4435357
• Product Code: KWT
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 320-35-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White