MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; OFF SHLDR GPS BLOCK L

Catalog Number	531-01-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
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 most likely cause of the reported event was a fracture which was likely caused during implantation of the shoulder or poor bone quality.Concomitant device(s): 300-01-09, equinoxe humeral stem primary, press fit 9mm; 320-38-00, equinoxe reverse 38mm humeral liner +0; 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-01-38, equinoxe reverse 38mm glenosphere; 320-15-01, eq rev glenoid plate.
Event or Problem Description
As reported by the clinical data study base, a (b)(6) y/o female patient presented for a 6-week postop l tsa exam and a coracoid fracture was noted.There was no additional treatment for the fracture.It is unknown when the fracture occurred, however, the ae report from the study states ¿post-op¿.The patient has a history of osteoarthritis and hypertension.It is noted that autograft was used behind the baseplate during the procedure and gps navigation was also used during the procedure.Patient outcome was noted as ¿continuing¿.There are no devices to be returned.

• Brand Name: EQUINOXE
• Common Device Name: OFF SHLDR GPS BLOCK L
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10559589
• Report Number: 1038671-2020-00527
• Device Sequence Number: 19489873
• Product Code: LXH
• UDI-Device Identifier: 10885862527769
• UDI-Public: 10885862527769
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: 531-01-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 107