MAUDE Adverse Event Report: EXACTECH, INC. UNKNOWN SHOULDER INSTRUMENT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-35-07
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via clinical study, that intra-op, the 76 yo female patient sustained a scapular fracture of the tip of the coracoid through anterior screw, likely from pull of anterior glenoid retractor.There was no action taken.The patient¿s outcome was last known as continuing.The case report form indicates this event is possibly related to device and definitely related to procedure.
Additional Manufacturer Narrative
Concomitants: serial #: (b)(4) category #: 320-40-00 - 145-deg pe 40mm hum liner +0.Serial #: (b)(4) category #: 300-30-09 - equinoxe preserve stem 9mm, serial #: (b)(4) category #: 320-31-40 - glenosphere, 40mm.Serial #: (b)(4) category #: 531-55-88 - ergo gps 3.2mm drill kit sterile.Serial #: (b)(4) category #: 320-15-05 - eq rev locking screw.Serial #: (b)(4) category #: 320-10-00 - equinoxe reverse tray adapter plate tray +0.Serial #: (b)(4) category #: 531-78-20 - shouldr gps hex pins kit.Serial #: (b)(4) category #: 320-20-00 - eq reverse torque defining screw kit.Serial #: (b)(4) category #: 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.Serial #: (b)(4) category #: 315-35-00 - glnd kwire.Serial #: (b)(4) category #: 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.Serial #: (b)(4) category #: 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.Serial #: (b)(4) category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4 (remove all from initial report-suspect device unknown), g4 (remove 501k from initial report-unknown), h2, h3, h4 (remove erroneous date from initial report), h6 health impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusion codes.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 bone fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: UNKNOWN SHOULDER INSTRUMENT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 16570566
• Report Number: 1038671-2023-00457
• Device Sequence Number: 1583559
• Product Code: KWT
• UDI-Device Identifier: 10885862534910
• UDI-Public: 10885862534910
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 320-35-07
• Device Catalogue Number: 320-35-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 03/19/2023
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White