MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM INSERTER

Catalog Number	301-09-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a procedure on a male patient, the plastic grommet stripped not allowing the stem to fully engage on the inserter.There were no pieces left in the patient.Patient was last known to be in stable condition following the event.Device to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the broken instrument reported was likely the result of repeated cleaning and sterilization cycles and exposure to impaction forces which led to crack initiation, propagation, and ultimate fracture of the stem inserter sphere subcomponent.(d4) lot number: 140639001.Section h11: the following sections have corrected information: (d2) common device name: humeral stem inserter (d4) catalog number: 301-09-10, unique identifier (udi) #: (b)(4).

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM INSERTER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10859836
• Report Number: 1038671-2020-00622
• Device Sequence Number: 16859792
• Product Code: LXH
• UDI-Device Identifier: 10885862557698
• UDI-Public: 10885862557698
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 301-09-10
• Device Lot Number: 140639001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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