MAUDE Adverse Event Report: EXACTECH, INC. MDLR RVS RMR 46MM CNLTD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	321-35-46
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that while reaming the glenoid, it fractured off the square piece that attaches to the tri drive.Rep believes the tech did not fully seat the reamer on the tri drive and when he started reaming.Nothing was damaged on the patients end.No fragments, parts or pieces fell into the patient.It fractured outside the 81 y/o male patient and from the tri drive connection piece most distal.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Device is returning.
Additional Manufacturer Narrative
(h3) the broken cannulated reamer reported may have been due to incomplete seating of the reamer on the tri-driver prior to use, which led to fracturing of the reamer post during reaming.Section h11: the following sections have corrected information: (h6) component code: 912, post.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury, nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: MDLR RVS RMR 46MM CNLTD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15409929
• Report Number: 1038671-2022-01096
• Device Sequence Number: 12167563
• Product Code: JXH
• UDI-Device Identifier: 10885862087829
• UDI-Public: 10885862087829
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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: 321-35-46
• Device Catalogue Number: 321-35-46
• Device Lot Number: 133341008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 02/20/2023; 02/03/2026
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 03/03/2023; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Age: 80 YR
• Patient Sex: Male