MAUDE Adverse Event Report: ARTHREX, INC. SIZE 12 LEG, GLENOID TARGETER; PROSTHESIS, SHOULDER, CEMENTED

Model Number	SIZE 12 LEG, GLENOID TARGETER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/12/2024, it was reported by a sales representative via sems-06635512 that an ar-5400-12 vip¿ glenoid targeter arm broke.This occurred during use, with no adverse effects on the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-5400-12 vip¿ glenoid targeter leg batch number: ar10040201 was received for investigation.Visual evaluation of the returned device noted that the shaft of the device was bent and the device had scratches on the surface.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.

• Brand Name: SIZE 12 LEG, GLENOID TARGETER
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20128564
• Report Number: 1220246-2024-07345
• Device Sequence Number: 7399188
• Product Code: KWS
• UDI-Device Identifier: 00888867315396
• UDI-Public: 00888867315396
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: SIZE 12 LEG, GLENOID TARGETER
• Device Catalogue Number: AR-5400-12
• Device Lot Number: AR10040201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• 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 Sex: Unknown