MAUDE Adverse Event Report: ARTHREX, INC. COMPRESSION SLEEVE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	COMPRESSION SLEEVE
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
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 is not confirmed.One unpackaged 5032-000 was received for investigation.Visual inspection concluded without observance of breakage to the o-ring.The device was compared to a test sample, with no differences noted in the condition of the o-ring components.No problem found.
Event or Problem Description
On 10/25/2021, it was reported by a sales representative via email that a 5032-000 compression sleeve's rubber "o" ring made its way out when the "lefty" lag screw was inserted.This occurred during a procedure on (b)(6) 2021.Surgeon was able to complete procedure without the "o" ring and assured the lag screw was inserted with great compression function.During inspection of the compression sleeve after the case, it was determine that the "o" ring appeared to be cut in two.

• Brand Name: COMPRESSION SLEEVE
• 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: 19567592
• Report Number: 1220246-2024-06117
• Device Sequence Number: 12506109
• Product Code: HSB
• UDI-Device Identifier: 00848665036480
• UDI-Public: 00848665036480
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• 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
• Report Date (Section B): 06/19/2024

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: COMPRESSION SLEEVE
• Device Catalogue Number: 5032-000
• Device Lot Number: 212020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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