MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RV RMR 38MM PLT TIP

Catalog Number	321-25-38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during the reamer part of a reverse shoulder procedure, the patient was large and exposure was tough.The surgeon tried to ream a posterior/superior right augment with the pilot tip reamer, instead of the cannulated option after removing the k-wire due to some difficulty working with the glenoid.It was also very hard bone.The pilot tip of the reamer then broke off inside of the patient and he had to use a manual tool to remove the tip from the patient.There was no patient impact and the situation was resolved rather quickly.
Additional Manufacturer Narrative
Section h10: (h3) the risk documentation was lacking specific failures for this type of defect for these instruments.In addition, the surgical technique was not providing information to the user of the instrument that reamng off axis can damage or break the instruments.Additionally, the surgical technique did not provide adequate instruction to the user *no information provided in the following section(s): a2, a3, a4, a5, b6, b7, d6, d7, g5, g8, h4, h7, h9.

• Brand Name: EQUINOXE
• Common Device Name: MDLR RV RMR 38MM PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9403609
• Report Number: 1038671-2019-00589
• Device Sequence Number: 16701980
• Product Code: KWT
• UDI-Device Identifier: 10885862087621
• UDI-Public: 10885862087621
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/27/2020

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: 321-25-38
• Device Lot Number: 60934013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/27/2020
• 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