MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR PRM RMR LG PLT TIP

Catalog Number	315-25-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
As reported, during an initial implant for this (b)(6) y/o female patient, the surgeon had sequentially reamed the glenoid with xs, sm, and med primary pilot tipped glenoid reamers.As the surgeon started to use the large reamer, it broke actual domed reamer section loose from the "center" section, which attaches to the reamer handle, and the "center" piece subsequently created a large hole in the center of the glenoid, which is where the surgeon had intended to place the cage portion of the caged glenoid.There were pieces were removed.The surgeon proceeded with the primary total shoulder replacement.There was a 15-30-minute delay.No adverse event reported due to delay.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
(h3) based on previous similar investigations, the fractured reamer blades reported were likely the result of the reamer experiencing high loads possibly during off-axis reaming and/or contact with hard bone or a retractor which led to brittle fracture of the blades.

• Brand Name: EQUINOXE
• Common Device Name: MDLR PRM RMR LG 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: 11920812
• Report Number: 1038671-2021-00272
• Device Sequence Number: 14256696
• Product Code: LXH
• UDI-Device Identifier: 10885862085368
• UDI-Public: 10885862085368
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/10/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 315-25-14
• Device Lot Number: 47364016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 05/10/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female