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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2022

Event Type  malfunction  

Event Description

As reported, the drill bit utilized for procedure broke in two (2) pieces during use.Both portions retrieved.No additional information available.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

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.

• Brand Name: EQUINOXE REVERSE SHOULDER DRILL KIT
• Type of Device: 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15658184
• MDR Text Key: 302570253
• Report Number: 1038671-2022-01345
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862087584
• UDI-Public: 10885862087584
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE SHOULDER DRILL KIT
• Device Catalogue Number: 321-20-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1