MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SQR DRV RTCHT WRNCH CXN

Model Number	321-15-21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that the device has fractured when force was applied to the snap off screw.Surgeon removed the parts and pieces that fell into the patient's wound.There was no surgical delay/prolongation.Device is returning.
Additional Manufacturer Narrative
Section h10: (d4) lot number: 64218008.(h3) the broken device reported was likely the result of applying a bending moment to the tip of the driver likely while tightening the torque defining screw which led to crack initiation, propagation, and ultimate failure.Section h11: the following sections have corrected information: (h6) component code: 431, adapter (adaptor).

• Brand Name: EQUINOXE
• Common Device Name: SQR DRV RTCHT WRNCH CXN
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14645503
• Report Number: 1038671-2022-00660
• Device Sequence Number: 20263874
• Product Code: LXH
• UDI-Device Identifier: 10885862087515
• UDI-Public: 10885862087515
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 321-15-21
• Device Catalogue Number: 321-15-21
• Device Lot Number: 64218008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown