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

Model Number GLENOID TARGETER SHAFT

Device Problem Defective Device (2588)

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

Event Date 03/28/2024

Event Type  malfunction  

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 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.

• Brand Name: GLENOID TARGETER SHAFT
• Type of Device: 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
• MDR Text Key: 341043272
• Report Number: 1220246-2024-02244
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: 00888867315334
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: GLENOID TARGETER SHAFT
• Device Catalogue Number: AR-5400-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1