MAUDE Adverse Event Report: EXACTECH, INC. GLND KWIRE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLND KWIRE
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during surgical procedure the 2.0mm k-wire fractured during glenoid reaming with 38mm cannulated reamer.Approx.1.5cm of the distal tip fractured.Fractured tip was unable to be retrieved.Standard glenoid based plate inserted without issue.The reverse total shoulder procedure continued without incident.All glenoid components (glenoid baseplate/screws / glenosphere) implanted without issue.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Device is not returning, sent to pathology at hospital.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) the broken device reported may have been the result of applying a bending moment to the wire which led to fracture of the tip.However, this cannot be confirmed because the component was not returned for evaluation.Section h11: the following sections have corrected information: (h6) component code: 829, guide.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d8, g1, h6 - medical device problem code, component code, investigation findings, investigation conclusions and h11.The broken device reported may have been the result of applying a bending moment to the wire which led to fracture of the tip.However, this cannot be confirmed because the component was not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: GLND KWIRE
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15879638
• Report Number: 1038671-2022-01526
• Device Sequence Number: 14079880
• Product Code: KWT
• UDI-Device Identifier: 10885862085658
• UDI-Public: 10885862085658
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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: GLND KWIRE
• Device Catalogue Number: 315-35-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 02/17/2023; 03/24/2026
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 03/03/2023; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 67 YR
• Patient Sex: Female