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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, impactor tip snapped in half during impaction of humeral liner.Surgery was a revision of a shoulder spacer to a reverse.Humeral components were being cemented in with humeral liner, humeral tray and stem already assembled.On the initial impaction the stem was still very proud at the time of the first impaction the 38mm impactor tip snapped in half.There were no pieces that fell into patient or wound site.Patient was last known to be in stable condition following the event.Image received.The device is not available for evaluation due to device was stuck in cement so hospital disposed the device.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) based on historical complaint investigations, the image provided, and the reported event, the fractured humeral liner impactor tip reported was likely the result of a stress riser introduced during impaction, which led to crack initiation, propagation, and ultimate fracture.Additionally, the device may have experienced material degradation if sterilized beyond the recommended parameters listed in the reprocessing instruction which could have led to the observed failure.The most probable root cause associated with the reported event of ¿broken / non-functional¿ is associated with a partial or full-thickness crack in the device materials.

• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16671302
• Report Number: 1038671-2023-00580
• Device Sequence Number: 5924549
• Product Code: KWT
• 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): 05/26/2026

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: HUM LNR IMPACT TIP 38M
• Device Catalogue Number: 321-07-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/27/2023; 04/29/2026
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/22/2023; 05/26/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female