MAUDE Adverse Event Report: ARTHREX, INC. SHAVER HP, SYNERGY, HANDCONTROL; POWERED SURG ORTHOPEDIC INSTR

Model Number	SHAVER HP, SYNERGY, HANDCONTROL
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(no problem found) the evaluation did not reveal any issues relevant to the reported event, "an ar-8332h shaver was found with bioburden in them.
Event or Problem Description
On 05/28/2024, it was reported by a sales representative via (b)(4) that an ar-8332h shaver was found with bio-burden in them.Discovered in case, patient not affected.

• Brand Name: SHAVER HP, SYNERGY, HANDCONTROL
• 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: 19593752
• Report Number: 1220246-2024-06369
• Device Sequence Number: 19825915
• Product Code: HWE
• UDI-Device Identifier: 00888867123991
• UDI-Public: 00888867123991
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/24/2024

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, SYNERGY, HANDCONTROL
• Device Catalogue Number: AR-8332H
• Device Lot Number: 14978619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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