MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 36MM HUMERAL LINER +0 UNCONSTRAINED

Model Number	320-36-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-30-08, equinoxe preserve stem 8mm.320-10-00, equinoxe reverse tray adapter plate tray +0.320-31-36, glenosphere, 36mm.320-35-02, small superior augment glenoid plate.
Event or Problem Description
As reported, approximately 4 months post the l reverse tsa, this (b)(6) female patient tried to lift a can of soda and felt a pop in the region of her l shoulder with increased pain, decreased range of motion.A revision was completed to repair an acromial fracture.The patient was discharged with orders for relative rest, referral to pain management for discussion of a nerve block in the intrascapular region.Outcome is reported as continuing.Device will not return due to clinical study policy.
Additional Manufacturer Narrative
Section h10: (h3) 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 most likely cause of the reported event was a fracture which was likely caused during implantation of the shoulder.

• Brand Name: EQUINOXE
• Common Device Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• 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: 12317875
• Report Number: 1038671-2021-00384
• Device Sequence Number: 14141661
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2021

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 Model Number: 320-36-00
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/21/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White