MAUDE Adverse Event Report: EXACTECH, INC. INSERTER, SMALL GLENOID PLATE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	321-35-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, the surgeon was impacting the baseplate and went to remove the inserter to check that it was fully seated and the small baseplate inserter tip came apart.Fragments/parts/pieces fell into the patient wound site and were removed, and the surgeon and pa both confirmed that no pieces remained within.There was a surgical delay/prolongation of an unknown amount of time to check for pieces and switch the to the liner inserter to further seat the baseplate.There were no adverse events as a result.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

• Brand Name: INSERTER, SMALL GLENOID PLATE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19319000
• Report Number: 1038671-2024-01255
• Device Sequence Number: 12351867
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/01/2026

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 Catalogue Number: 321-35-24
• Device Lot Number: 326597002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 10/01/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female