MAUDE Adverse Event Report: EXACTECH, INC. HUM LNR IMPACT TIP 38M; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	HUM LNR IMPACT TIP 38M
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
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, the humeral stem was in the assembly tray during impaction.The humeral liner impactor tip 38mm broke during the impaction of the 38 humeral liner.All fragments, parts or pieces were removed.The surgeon stated the humeral liner was not damaged.Surgery carried on as normal, there was no delay.Image received.The device will be return.No patient information provided.
Additional Manufacturer Narrative
H2: the fractured impactor tip reported was likely the result of a stress riser introduced during impaction, which led to crack initiation, propagation, and ultimate fracture of the device.Additionally, the device may have experienced material degradation if sterilized beyond the recommended parameters listed in the reprocessing instructions which could have led to the observed failure.Correction: h6 problem code, impact code, clinical code.
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: HUM LNR IMPACT TIP 38M
• 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: 19281170
• Report Number: 1038671-2024-01164
• Device Sequence Number: 12660574
• Product Code: KWT
• UDI-Device Identifier: 10885862087171
• UDI-Public: 10885862087171
• 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,Followup
• Report Date (Section B): 12/02/2025

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: HUM LNR IMPACT TIP 38M
• Device Catalogue Number: 321-07-38
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 11/25/2025
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/22/2024; 12/03/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown