MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUM LNR IMPACT TIP 38M

Catalog Number	321-07-38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the impactor tip cracked in half upon impaction of 38 humeral liner.There were no parts or pieces left in the patient.There was no delay in the procedure.Parts returned to head office.The patient did not experience any adverse issues due the event.Device to be returned.
Additional Manufacturer Narrative
Section h10: (h3) based on historical complaint investigations and the returned device, the fractured humeral liner impactor tip reported was likely the result of a stress riser introduced during impaction, which led to crack initiation, propagation, and ultimate fracture.Additionally, the device may have experienced material degradation if sterilized beyond the recommended parameters listed in the reprocessing instruction which could have led to the observed failure.

• Brand Name: EQUINOXE
• Common Device Name: HUM LNR IMPACT TIP 38M
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11663318
• Report Number: 1038671-2021-00169
• Device Sequence Number: 2899163
• Product Code: LXH
• UDI-Device Identifier: 10885862087171
• UDI-Public: 10885862087171
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 321-07-38
• Device Lot Number: 74360010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention