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 Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a primary procedure on this (b)(6) y/o male patient, the center piece of the primary large pilot reamer detached from the outer cage during reaming.It slightly enlarged the center cage hole, requiring cementing of the glenoid cage.Extra time had to be taken to cement the center cage of prosthesis, approximately 5-15 mins.Patient was last known to be in stable condition following the event.Instrument to be returned.No parts or pieces of the device fell into the patient wound site.(b)(4).
Additional Manufacturer Narrative
Section h10: (d4) lot number: 119750001.(h3) based on previous similar investigations, the broken reamer reported was likely the result of reaming off-axis under high loads or accidentally contacting the retractors while reaming.However this cannot be confirmed as no information regarding its surgical use was reported for this case.

• Brand Name: EQUINOXE
• Common Device Name: MDLR PRM RMR LG PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10403606
• Report Number: 1038671-2020-00480
• Device Sequence Number: 3066054
• Product Code: LXH
• UDI-Device Identifier: 10885862085368
• UDI-Public: 10885862085368
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 315-25-14
• Device Lot Number: 119750001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR