MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER SHAFT; VIRTUAL IMPLANT POSITIONING

Model Number	GLENOID TARGETER SHAFT
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/09/2024, it was reported by a sales representative via (b)(4) that an ar-5400-01 glenopid targeter shaft is not locking into the leg.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was determined that the edges around the vip¿ glenoid targeter, titanium shaft had chipped and abrasion marks on the distal end of the shaft.Functional testing was performed, and the targeted legs did not slide as required.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage and chipped edges of the glenoid targeter.

• Brand Name: GLENOID TARGETER SHAFT
• Common Device Name: VIRTUAL IMPLANT POSITIONING
• 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: 19235030
• Report Number: 1220246-2024-02732
• Device Sequence Number: 12507583
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: 00888867315334
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/29/2024

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: GLENOID TARGETER SHAFT
• Device Catalogue Number: AR-5400-01
• Device Lot Number: 022201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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