MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; NARROW REV 42MM REAMER MODULAR, CANNULATED

Catalog Number	321-55-42
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, while reaming the glenoid of a patient, the butterfly reamers were spinning on the face.The surgeon was adamant that the reamers are too blunt for hard bone and that they should be replaced.
Additional Manufacturer Narrative
Section h10: (h3) engineering evaluation noted that the reported event of the dull reamers were likely the result of repeated use and sterilization cycles, which may have led to the blades becoming too blunt.However, this event was also reported in error.Dull reamers do not have the potential to lead to a serious injury.

• Brand Name: EQUINOXE
• Common Device Name: NARROW REV 42MM REAMER MODULAR, CANNULATED
• 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: 12445477
• Report Number: 1038671-2021-00469
• Device Sequence Number: 14336738
• Product Code: LXH
• UDI-Device Identifier: 10885862232779
• UDI-Public: 10885862232779
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 321-55-42
• Device Lot Number: 281176012
• 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: 08/19/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 02/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown