MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; LP TALAR IMPACTOR INSERT

Catalog Number	351-07-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
While impacting the talus implant the plastic talar impactor cover broke."there we no parts or pieces created by the break that could have fallen into the patient.All of the pieces were recovered and disposed of." patient was last known to be in stable condition following the event.Device will not return; disposed of by hospital.
Additional Manufacturer Narrative
Section h10: (h3) the fractured vantage lp impactor insert reported was most likely the result of a stress riser introduced during impaction which led to crack initiation, propagation, and ultimate fracture of the device.However, this cannot be confirmed as the device was not available for evaluation.Section h11: *the following sections have corrected information: (h8) usage of device: unknown.

• Brand Name: EQUINOXE
• Common Device Name: LP TALAR IMPACTOR INSERT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10859738
• Report Number: 1038671-2020-00619
• Device Sequence Number: 11479018
• Product Code: LXH
• UDI-Device Identifier: 10885862563415
• UDI-Public: 10885862563415
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/03/2020

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: 351-07-04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: 75 YR