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

Model Number GLND KWIRE

Device Problem Break (1069)

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

Event Date 09/30/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

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

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.

• Brand Name: GLND KWIRE
• Type of Device: 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15879638
• MDR Text Key: 304468282
• Report Number: 1038671-2022-01526
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862085658
• UDI-Public: 10885862085658
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female