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	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.No information provided in the following section(s): age or date of birth, weight, ethnicity, relevant tests / laboratory data, other relevant history, preexisting medical conditions, implant date (2021 reports), explant date (2021 reports), was this device serviced by a third party?, returned to manufacturer, date received by manufacturer, adverse event, device manufacture date, recall (if recall number is given) or correction/removal number (if given) (2021 reports) , correction/removal number (2020 reports).
Event or Problem Description
As reported, the surgeon was using the instrument in an anatomic case on this male patient, he used a mallet to impact the head onto the stem and when he took the impactor head away from the head he noticed it has broken at the junction of the impactor head and the handle.The device will return for evaluation.
Additional Manufacturer Narrative
Section h10: (h3) based on previous complaint investigation and the returned device, the broken impactor handle reported was likely the result of not fully securing the impactor handle to a mating tip, and then impacting off-axis, which led to crack initiation, propagation, and ultimate failure of the threads on the handle.

• 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: 11964409
• Report Number: 1038671-2021-00283
• Device Sequence Number: 3404063
• Product Code: LXH
• UDI-Device Identifier: 10885862084316
• UDI-Public: 10885862084316
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: UNK
• 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): 04/19/2022

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: 142054018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 04/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male