MAUDE Adverse Event Report: EXACTECH, INC. NARROW REV 38MM REAMER MODULAR, PILOT TIP; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	NARROW REV 38MM REAMER MODULAR, PILOT TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported during surgery that a 38mm pilot tip reamer jammed and the pilot tip snapped.All pieces were removed from the patient.There was no surgical delay.The case proceeded without complications and a good outcome for the patient.Patient was last known to be in stable condition following the event.Image received.The device is available for evaluation.
Additional Manufacturer Narrative
H3: the broken device returned was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip feature.Section d: corrected catalog number and lot number; h6: corrected component code, type of investigation, investigation findings, investigation conclusions.

• Brand Name: NARROW REV 38MM REAMER MODULAR, PILOT TIP
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19641000
• Report Number: 1038671-2024-02211
• Device Sequence Number: 8609916
• Product Code: KWT
• UDI-Device Identifier: 10885862232724
• UDI-Public: 10885862232724
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NARROW REV 38MM REAMER MODULAR, PILOT TIP
• Device Catalogue Number: 321-25-38
• Device Lot Number: 400613007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/30/2024
• Supplement Report FDA Received Date: 09/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female