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

Model Number MDLR RVS RMR 38MM CNLTD

Device Problem Break (1069)

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

Event Date 09/12/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

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

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.

• Brand Name: MDLR RVS RMR 38MM CNLTD
• Type of Device: 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
• MDR Text Key: 324644073
• Report Number: 1038671-2023-02399
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862087805
• UDI-Public: 10885862087805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/01/2023
• 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
• Treatment: UNK.
• Patient Age: 69 YR
• Patient Sex: Female