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

Model Number	UNI GLENOID IMPACTOR FOR BASEPLT S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the white cap of the device cracked.There was no harm or adverse event for patient, operator or third party reported.No further information received.Update avoe (b)(6) 2021.It was confirmed that the error occurred during a shoulder arthroscopy surgery, but the crack in the white cap of the device was noticed after the surgery.No part of the device broke off.There was no harm or adverse event 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.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 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 reported event was partly confirmed as the cracked plastic cap was not sent in for evaluation.However the metal part of the impactor head broke off at the weld (see evaluation picture 2).The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces used during impacting.

• Brand Name: UNI GLENOID IMPACTOR FOR BASEPLT S
• 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: 19286445
• Report Number: 1220246-2024-03091
• Device Sequence Number: 8474088
• Product Code: LXH
• UDI-Device Identifier: 00888867057371
• UDI-Public: 00888867057371
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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 S
• Device Catalogue Number: AR-9120D-01
• Device Lot Number: 250140802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown