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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

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
• Type of Device: 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
• MDR Text Key: 312612025
• Report Number: 1038671-2023-00580
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862087171
• UDI-Public: 10885862087171
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female