MAUDE Adverse Event Report: EXACTECH, INC. REAMER; MDLR RV RMR 42MM PLT TIP

Model Number	MDLR RV RMR 42MM PLT TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the tip of a reamer broke off while reaming the glenoid.The tip of the reamer was easily retrieved, and an x-ray was taken at the end of the case and no pieces were left in the patient.No time was added to the case and the patient left the or in good health.The outcome of the case was good.Device was retrieved the broken tip and used another reamer in the set to complete the reaming.Broken part will be returned.
Additional Manufacturer Narrative
Section h10: (h3): based on capa: 2017-12, 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.(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.Section h11: the following sections have corrected information: type of reportable event: serious injury.

• Brand Name: REAMER
• Common Device Name: MDLR RV RMR 42MM PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9664218
• Report Number: 1038671-2020-00017
• Device Sequence Number: 3414005
• Product Code: LXH
• UDI-Device Identifier: 10885862087638
• UDI-Public: 10885862087638
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/15/2020

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 Model Number: MDLR RV RMR 42MM PLT TIP
• Device Catalogue Number: 321-25-42
• Device Lot Number: 49360010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 05/15/2020
• 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
• Patient Age: 80 YR