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

Catalog Number	321-20-00
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 2.0 mm drill broke while the surgeon was drilling the pilot hole.This event is related to the breakage of the device.All pieces that fell into the patient and/or the wound site were removed.The event did not cause a surgical delay/prolongation.The event is not related to a revision of exactech devices.No device return for analysis anticipated.The scrub placed the single use item in the sharps bin.A device image was provided.
Additional Manufacturer Narrative
Correction: h6: health effect clinical code, impact code, device problem code additional information: h3: based on historical complaint investigations, the broken drill bit reported was likely the result of applying a bending moment while the drill bit was passing through the drill guide which led to ultimate fracture of the device.H6: component code, investigation codes.

• Brand Name: EQUINOXE
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19707399
• Report Number: 1038671-2024-02335
• Device Sequence Number: 18012371
• Product Code: KWT
• UDI-Device Identifier: 10885862087584
• UDI-Public: 10885862087584
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 321-20-00
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 10/09/2024
• 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: Required Intervention
• Patient Sex: Unknown