MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID IMPACTOR TIP

Catalog Number	315-07-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a shoulder procedure on this (b)(6) y/o male, the secondary glenoid impactor broke while impacting the glenoid.All broken pieces were removed from the wound.The broken piece was thrown away after the case.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) based on similar previous complaint investigations, the fractured device reported was likely the result of crack initiation, propagation, and ultimate fracture of the device which was likely caused by abnormal or aggressive use inconsistent with the intended use of this device.Section h11: the following sections have corrected information: (h1) type of reportable event required: serious injury.

• Brand Name: EQUINOXE
• Common Device Name: GLENOID IMPACTOR TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10038532
• Report Number: 1038671-2020-00287
• Device Sequence Number: 19511672
• Product Code: LXH
• UDI-Device Identifier: 10885862251824
• UDI-Public: 10885862251824
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/02/2020

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: 315-07-06
• Device Lot Number: 115720020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR