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

Model Number HUMERAL STEM INSERTER

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event 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.

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
• Type of Device: HUMERAL STEM INSERTER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10155076
• MDR Text Key: 195242250
• Report Number: 1038671-2020-00307
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862557681
• UDI-Public: 10885862557681
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR