MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; ANKLE IMPACTOR HANDLE

Catalog Number	351-93-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): 351-10-13, 144998006 - fct gap check tl sz 3-4.
Event or Problem Description
As reported, impactor handle broke off connection tip to impactor assembly when impacting tibial implant.No part or pieces fell into the patient.Continued case without handle and impacted with broken assembly device.The patient was not adversely affected.The device will be returned.
Additional Manufacturer Narrative
H10: capa2019-58 investigation determined the failure observed during evaluation of the device indicates improper use during surgical procedure, as supported by durability testing, review of instrumentation design, and operative technique.
Additional Manufacturer Narrative
(h3) upon further review this event does not meet the criteria for reporting as the risk of injury is remote.This instrument captured in this report is attached to a handle and the fractured piece would likely be retained in the handle.

• Brand Name: VANTAGE
• Common Device Name: ANKLE IMPACTOR HANDLE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10778190
• Report Number: 1038671-2020-00595
• Device Sequence Number: 3884037
• Product Code: LXH
• UDI-Device Identifier: 10885862290793
• UDI-Public: 10885862290793
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/17/2020

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: 351-93-01
• Device Lot Number: 119730001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 11/12/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/13/2020; 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention