MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; NARROW REV 38MM REAMER MODULAR, PILOT TIP

Catalog Number	321-45-38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the pilot tip broke off of the reamer while reaming the glenoid, all pieces were removed from the wound and the patient was stable leaving the or.Pictures of the device to be sent.No other information available at this time.
Additional Manufacturer Narrative
Section h10: (h3) based on capa2017-12, the broken device reported was likely the result of applying a bending moment to the reamers during use, which led to brittle fractures of the pilot tip feature.(h7) recall (h9) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z2663-2017, z2664-2017, z2665-2017, z2666-2017, z2667-2017, z2668-2017.*no information provided in the following section(s): a2, a3, a4, a5, b6, b7, d6, d7, d11, g5, g8, h4, h7.

• Brand Name: EQUINOXE
• Common Device Name: NARROW REV 38MM REAMER MODULAR, PILOT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9480210
• Report Number: 1038671-2019-00606
• Device Sequence Number: 366282
• Product Code: KWT
• UDI-Device Identifier: 10885862232724
• UDI-Public: 10885862232724
• Combination Product (Y/N): N
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 321-45-38
• Device Lot Number: 123142005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 03/27/2020
• 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