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

Catalog Number 315-07-06

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

As reported, during the surgeon¿s routine impaction of an anatomic glenoid implant, the impactor tip broke into two pieces which were both easily retrieved.Nothing fell into the wound site.The (b)(6) male was not affected by the break.Patient was last known to be in stable condition following the event.Device is to be returned.

Manufacturer Narrative

Pending evaluation.

Manufacturer Narrative

Section h10: (d4) lot number: 92919002 (h3) based on previous complaint investigations, the reported event, and returned device, the fractured glenoid impactor tip reported in 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
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13052787
• MDR Text Key: 287019025
• Report Number: 1038671-2021-00715
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862251824
• UDI-Public: 10885862251824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 92919002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male