MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER DRILL KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	321-20-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon was drilling with the 2mm drill through the pilot hole of the modular glenoid plate drill guide when the drill broke.Surgery continued as normal.No fragment parts or pieces fell into the patient wound site.No patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
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.

• Brand Name: EQUINOXE REVERSE SHOULDER DRILL KIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32605 ; 3523771140
• MDR Report Key: 19484069
• Report Number: 1038671-2024-01794
• Device Sequence Number: 15447896
• Product Code: LXH
• UDI-Device Identifier: 10885862087584
• UDI-Public: 10885862087584
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 05/28/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown