MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUM HD IMPCTR

Catalog Number	311-07-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a procedure, the impactor tip broke off while impacting final humeral head.No pieces left in patient, no delay to surgery or adverse effects to the patient.The device will be returned.
Additional Manufacturer Narrative
(h3) the broken impactor handle reported was likely the result of not fully securing the impactor handle to the humeral head impactor tip and applying force to the impactor at an angle, eventually causing crack initiation, propagation, and ultimate shear fracture at the threads.Section h11: the following sections have corrected information: (section f10) please disregard health effect - impact code.These were entered in error.

• Brand Name: EQUINOXE
• Common Device Name: HUM HD IMPCTR
• 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: 12251883
• Report Number: 1038671-2021-00363
• Device Sequence Number: 20019328
• Product Code: LXH
• UDI-Device Identifier: 10885862084316
• UDI-Public: 10885862084316
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 11/15/2021

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: 311-07-05
• Device Lot Number: 28799023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 11/15/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown