MAUDE Adverse Event Report: ARTHREX, INC. SHAVER HP, ASPII, HAND CONTROL, BACKHAND; POWERED SURG ORTHOPEDIC INSTR

Model Number	SHAVER HP, ASPII, HAND CONTROL, BACKHAND
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 05/07/2024, it was reported by a sales representative via (b)(4) that an ar-8330rh shaver has some bio burden at the bottom of it, causing the shaver to not lock.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(no problem found) the evaluation did not reveal any issues relevant to the reported event, "on 05/07/2024, it was reported by a sales representative via sems-06559124 that an ar-8330rh shaver has some bio burden at the bottom of it, causing the shaver to not lock.This occurred during use in a case with no patient effect." although minimal bioburden found, attachment connected and locked into collet.

• Brand Name: SHAVER HP, ASPII, HAND CONTROL, BACKHAND
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 19460899
• Report Number: 1220246-2024-04852
• Device Sequence Number: 6812313
• Product Code: HWE
• UDI-Device Identifier: 00888867043244
• UDI-Public: 00888867043244
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K932699
• 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,Followup
• Report Date (Section B): 12/04/2024

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: SHAVER HP, ASPII, HAND CONTROL, BACKHAND
• Device Catalogue Number: AR-8330RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2015
• 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