MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID IMPACTOR TIP

Catalog Number 315-07-06

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, during a procedure on a (b)(6) y/o male patient, the surgeon impacted the glenoid component with the plastic black tip, it fractured in half.The broken impactor tip pieces were removed from the wound.The patient was last known to be in stable condition following the event.The device is available for return.

Manufacturer Narrative

Lot number: 60383001.(h3) based on historical complaint investigations and the returned device, the fractured device reported was likely the result of crack initiation, propagation, and ultimate fracture of the device which was likely caused by abnormal or aggressive use inconsistent with the intended use of this device.

• Brand Name: EQUINOXE
• Type of Device: GLENOID IMPACTOR TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10038630
• MDR Text Key: 190360741
• Report Number: 1038671-2020-00289
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862251824
• UDI-Public: 10885862251824
• 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: 06/15/2020

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 Catalogue Number: 315-07-06
• Device Lot Number: 60383001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR