MAUDE Adverse Event Report: EXACTECH, INC. MDLR RVS RMR 46MM CNLTD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 321-35-46

Device Problem Break (1069)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that while reaming the glenoid, it fractured off the square piece that attaches to the tri drive.Rep believes the tech did not fully seat the reamer on the tri drive and when he started reaming.Nothing was damaged on the patients end.No fragments, parts or pieces fell into the patient.It fractured outside the 81 y/o male patient and from the tri drive connection piece most distal.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Device is returning.

Manufacturer Narrative

(h3) the broken cannulated reamer reported may have been due to incomplete seating of the reamer on the tri-driver prior to use, which led to fracturing of the reamer post during reaming.Section h11: the following sections have corrected information: (h6) component code: 912, post.

• Brand Name: MDLR RVS RMR 46MM CNLTD
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15409929
• MDR Text Key: 299772417
• Report Number: 1038671-2022-01096
• Device Sequence Number: 1
• Product Code: JXH
• UDI-Device Identifier: 10885862087829
• UDI-Public: 10885862087829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 321-35-46
• Device Catalogue Number: 321-35-46
• Device Lot Number: 133341008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male