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

Catalog Number	311-07-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a shoulder procedure for this (b)(6) y/o male patient, during the final impaction of the humeral head by the surgeon, part of the impaction tip broke off.As the head had already been impacted sufficiently no further impaction was required.The broken part was retrieved and sent to cssd along with the rest of the instruments.One large piece broke off, so it was easy for the surgeon to remove.Unfortunately, the broken part did not materialize after decontamination and therefore has not been returned.Patient was last known to be in stable condition following the event.Device to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the broken device reported was likely the result of crack initiation, propagation, and ultimate fracture of the radel impaction surface related to surgical use and subsequent sterilization cycles.

• Brand Name: EQUINOXE
• Common Device Name: HUM HD IMPCTR TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10711069
• Report Number: 1038671-2020-00583
• Device Sequence Number: 11737153
• Product Code: LXH
• UDI-Device Identifier: 10885862084330
• UDI-Public: 10885862084330
• 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): 11/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 311-07-07
• Device Lot Number: 62808005
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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
• Patient Age: 66 YR