MAUDE Adverse Event Report: EXACTECH, INC. GLEN BASEPLATE IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	321-19-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, during impaction the impactor tip was damaged.All parts of the tip were retrieved from the patient.The event is not associated with a revision.There was no reported surgical delay/prolongation.No patient information reported.
Additional Manufacturer Narrative
H3: the broken glenoid baseplate inserter reported may have been due to the device being subjected to repeat forces over numerous surgical uses, which led to failure of the weld holding the dowel pin onto the baseplate inserter, and ultimately resulted in disassembly of the subcomponents.

• Brand Name: GLEN BASEPLATE IMPACTOR
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16853355
• Report Number: 1038671-2023-00885
• Device Sequence Number: 18054390
• Product Code: LXH
• UDI-Device Identifier: 10885862558459
• UDI-Public: 10885862558459
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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 Model Number: 321-19-13
• Device Catalogue Number: 321-19-13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 05/05/2026
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/20/2023; 05/28/2026
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown