MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RV RMR 38MM PLT TIP

Catalog Number	321-25-38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the surgeon was reaming the glenoid using the pilot-tipped 38mm glenoid reamer and the tip broke off inside of patient.The pilot tip of glenoid reamer pilot tip was retrieved after creating space within the hole.After retrieval of glenoid tip, reverse shoulder continued without issue.Patient was last known to be in stable condition following the event.There was a reported delay of 5-15 minutes with no consequences to the patient noted.The device will be returned.
Additional Manufacturer Narrative
Section h10: (d4) lot number: 259380037.(h3) based on capa2017-12 and capa2019-48, the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip feature.(h7) recall.(h9) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z-2663-2017, z-2664-2017, z-2665-2017, z-2666-2017, z-2668-2017, z-2668-2017.

• Brand Name: EQUINOXE
• Common Device Name: MDLR RV RMR 38MM PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11143347
• Report Number: 1038671-2021-00002
• Device Sequence Number: 14463617
• Product Code: LXH
• UDI-Device Identifier: 10885862087621
• UDI-Public: 10885862087621
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 321-25-38
• Device Lot Number: 259380037
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention