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

Model Number	EQUINOXE REVERSE SHOULDER DRILL KIT
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the drill bit utilized for procedure broke in two (2) pieces during use.Both portions retrieved.No additional information available.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(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.The most probable root cause associated with the reported event of "broken - retrieved from patient¿ is associated with a partial or full-thickness crack in the device materials.Section d9: device available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g1, h6 - medical device problem code, component code, investigation findings, investigation conclusion and h11.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE SHOULDER DRILL KIT
• 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: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15658184
• Report Number: 1038671-2022-01345
• Device Sequence Number: 17758174
• Product Code: KWT
• UDI-Device Identifier: 10885862087584
• UDI-Public: 10885862087584
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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 Model Number: EQUINOXE REVERSE SHOULDER DRILL KIT
• Device Catalogue Number: 321-20-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 01/16/2023; 03/13/2026
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 02/06/2023; 03/19/2026
• 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
• Patient Sex: Unknown