MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM

Model Number UNKNOWN

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to infection.It was infected and loose.

Manufacturer Narrative

The revision reported was likely the result of infection.However, this cannot be confirmed as the devices were not available for evaluation, and no further information was provided.

• Brand Name: EQUINOXE
• Type of Device: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8477604
• MDR Text Key: 140736829
• Report Number: 1038671-2019-00204
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086563
• UDI-Public: 10885862086563
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/19/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: 320-20-34
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 40