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

Model Number	HUMERAL STEM INSERTER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a surgical procedure of a (b)(6) female patient, a rubber piece broke off of a humeral stem inserter.The parts or pieces of the device did not fall into the patient wound.The device is to be returned.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the broken instrument reported was likely the result of repeat cleaning and sterilization cycles and exposure to impaction forces which likely led to crack initiation, propagation, and ultimate fracture of the stem inserter sphere.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM INSERTER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10155076
• Report Number: 1038671-2020-00307
• Device Sequence Number: 19343505
• Product Code: KWT
• UDI-Device Identifier: 10885862557681
• UDI-Public: 10885862557681
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/21/2020

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 Model Number: HUMERAL STEM INSERTER
• Device Catalogue Number: 301-09-10
• Device Lot Number: 146039001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/21/2020
• 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: 64 YR