MAUDE Adverse Event Report: EXACTECH, INC. CALCAR PLANER, 1.5 BLADE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	01-003-04-0002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
During surgical use, we were in a primary tha case with dr.(b)(6) at uchealth in denver, co on 12/01/23.The calcar planer blade broke while calcar planning the femur.The blade might have hit one of the retractors as to how it happened.The spiral pieces on the center of the blade itself fell off the shaft.Patient was fine, femur did not break.
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: CALCAR PLANER, 1.5 BLADE
• 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: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18411395
• Report Number: 1038671-2023-03068
• Device Sequence Number: 12884131
• Product Code: LXH
• UDI-Device Identifier: 10885862257345
• UDI-Public: 10885862257345
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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
• Device Catalogue Number: 01-003-04-0002
• Device Lot Number: 142457002
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 07/02/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Female