MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL STEM INSERTER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	HUMERAL STEM INSERTER
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, during procedure the black plastic tip of the humeral stem inserter sheered of the impactor and the entire mech disassembled.There were no parts or pieces of the device that fall into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The device is available for evaluation.
Additional Manufacturer Narrative
The broken stem inserter reported may have been the result of exposure to numerous impaction forces, which led to crack initiation, propagation, and ultimate fracture of the stem inserter sphere subcomponent, which led to disassembly of the humeral stem inserter.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a.The broken stem inserter reported may have been the result of exposure to numerous impaction forces, which led to crack initiation, propagation, and ultimate fracture of the stem inserter sphere subcomponent, which led to disassembly of the humeral stem inserter.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: HUMERAL STEM INSERTER
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 19570851
• Report Number: 1038671-2024-02019
• Device Sequence Number: 14987645
• Product Code: KWS
• UDI-Device Identifier: 10885862580443
• UDI-Public: 10885862580443
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• 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,Followup
• Report Date (Section B): 05/06/2025

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: HUMERAL STEM INSERTER
• Device Catalogue Number: 301-09-20
• Device Lot Number: 407509005
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 05/06/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/11/2024; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Male
• Patient Weight: 80 KG