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

Catalog Number	315-07-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Pending evaluation.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2021-00715
• Device Sequence Number: 3888142
• Product Code: KWT
• UDI-Device Identifier: 10885862251824
• UDI-Public: 10885862251824
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 315-07-06
• Device Lot Number: 92919002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male