MAUDE Adverse Event Report: EXACTECH, INC. MDLR RVS RMR 38MM CNLTD; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	MDLR RVS RMR 38MM CNLTD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during surgical use, the surgeon was rearing the glenoid and went up to the 38 reamer and it caught a piece of the superior glenoid and bound up at the end of his reaming.Surgeon handed the reamer back to the tech and she noticed that the reamer had broken when it caught the superior glenoid.No broken pieces, parts fell into patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The device will be return.No other patient information/medical history reported.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken device reported was likely the result of the reamer unexpectedly catching on unprepared bone and subsequent rapid application of a counterforce to the instrument greater than yield strength of the material, which led to crack initiation, propagation, and ultimate failure.The most probable root cause associated with the event of ¿broken / non-functional¿ is cause traced to component failure.
Additional Manufacturer Narrative
H6: corrected component code.

• Brand Name: MDLR RVS RMR 38MM CNLTD
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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 ; 3523771140
• MDR Report Key: 17840865
• Report Number: 1038671-2023-02399
• Device Sequence Number: 4386493
• Product Code: HSD
• UDI-Device Identifier: 10885862087805
• UDI-Public: 10885862087805
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2024

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: MDLR RVS RMR 38MM CNLTD
• Device Catalogue Number: 321-35-38
• Device Lot Number: 1346552010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/01/2023; 11/11/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/03/2023; 11/11/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Female