MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RV RMR 46MM PLT TIP

Catalog Number 321-25-46

Device Problem Break (1069)

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

Event Date 01/13/2022

Event Type  Injury  

Event Description

It was reported that during surgical use, the tip of the reamer broke off while reaming the glenoid.Broken piece was easily removed.No time was added to the surgery and patient left the or in good health.

Manufacturer Narrative

Pending evaluation.

Manufacturer Narrative

Section h10: (h3) the broken device reported was likely the result of applying a bending moment to the reamer during use, which let to brittle fracture of the pilot tip.

• Brand Name: EQUINOXE
• Type of Device: MDLR RV RMR 46MM PLT 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: 13423577
• MDR Text Key: 288034594
• Report Number: 1038671-2022-00135
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862087645
• UDI-Public: 10885862087645
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-46
• Device Lot Number: 109536032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 03/01/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male