MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID IMPACTOR FOR BASEPLT M; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNI GLENOID IMPACTOR FOR BASEPLT M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder prosthesis surgery the impactor was defective.It was reported that it rotates around its own axis.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update dw 01-dec-2023.The returned device was evaluated and it was found that the front part of the device became detached as the screw did not hold inside the driver anymore.
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
Additional information: d9, g3, h6.Complaint is confirmed.Visual inspection identified the impactor head medium, impactor insert, and impactor screw were detached from the arthrex universal glenoid¿ impactor for baseplate medium.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.The device was manufactured in 2017.

• Brand Name: UNI GLENOID IMPACTOR FOR BASEPLT M
• 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: emily shafer ; 8009337001
• MDR Report Key: 18369033
• Report Number: 1220246-2023-09540
• Device Sequence Number: 12714207
• Product Code: LXH
• UDI-Device Identifier: 00888867057388
• UDI-Public: 00888867057388
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: UNI GLENOID IMPACTOR FOR BASEPLT M
• Device Catalogue Number: AR-9120D-02
• Device Lot Number: 250161003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown