MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER SHAFT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GLENOID TARGETER SHAFT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 3/28/2024, it was reported by a sales representative via sems-06526980 that an ar-5400-01 glenoid targeter shaft "b" slot was not locking down with a leg placed in it when setting up with the scrub tech.They tightened the capture nut and the leg, but would still not lock in.They tried using many legs of different sizes to see if this was the issue, but it persisted.The case was completed successfully, and no further information was provided.This was discovered when setting up with the scrub tech for a reverse total shoulder arthroplasty procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is not confirmed.One unpackaged ar-5400-01 serial/batch number 022139 was received for investigation.However, the mating parts were not received.Visual evaluation noted nicks and the edges of the slots for the attachments.Functional testing found that the device does slide in and out of the matting part without issues.And the legs locked into place.No problem found.

• Brand Name: GLENOID TARGETER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19163991
• Report Number: 1220246-2024-02244
• Device Sequence Number: 7949459
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: 00888867315334
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/09/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 09/09/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown