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

Model Number	GLENOID TARGETER HANDLE
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to wear and tear.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).
Event or Problem Description
On 08/19/2022, it was reported by a sales representative via (b)(4) that an ar-5400-02 glenoid targeter handle and an ar-5400-01 glenoid targeter shaft had an issue.During an unspecified procedure, the ar-5400-01 glenoid targeter shaft slot a would not allow the arm to slide in, and the ar-5400-02 glenoid targeter handle would not allow the arm to slide into the a slot.This was discovered during use with no impact to the patient.Additional information was requested.On 08/31/2022, the sales representative stated the following information via phone: this event occurred during a reverse total shoulder procedure on (b)(6) 2022.The surgeon used a hemostat to guide the device into the a slot, and both devices then were used to complete the case successfully with no impact to the patient.These instruments could not be used anymore after the completion of the case.

• Brand Name: GLENOID TARGETER HANDLE
• 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: 19370506
• Report Number: 1220246-2024-03643
• Device Sequence Number: 15335617
• Product Code: KWS
• UDI-Device Identifier: 00888867315341
• UDI-Public: 00888867315341
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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 HANDLE
• Device Catalogue Number: AR-5400-02
• Device Lot Number: 052021
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown