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

Catalog Number	321-25-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
During a procedure on this (b)(6) y/o male, as the surgeon started to ream with the starter pilot tip reamer, the tip broke away.It was suctioned out of the patient and unrecoverable.C arm x-ray confirmed the tip was no longer in the patient.Patient was last known to be in stable condition following the event.Minor inconvenience, no patient issues due to instrument breakage.The device (without the tip) will be returned.
Additional Manufacturer Narrative
Section h10: (h3) the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to a brittle fracture of the pilot tip feature section.H11: *the following sections have corrected information: (section f) please disregard f10, health effect - impact code.These were entered in error.

• Brand Name: EQUINOXE
• Common Device Name: MDLR RV RMR STRT 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: 12172460
• Report Number: 1038671-2021-00343
• Device Sequence Number: 16549741
• Product Code: LXH
• UDI-Device Identifier: 10885862087614
• UDI-Public: 10885862087614
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/10/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 321-25-01
• Device Lot Number: 52199006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 11/10/2021
• 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: 56 YR
• Patient Sex: Male