MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT AR-SCOPE,30°4X152.5MM LGTH; ARTHROSCOPE AND ACCESSORIES

Model Number	C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems (b)(4)that an ar-3355-4030 scope top of the housing is loose (where you twist it to attach to and from the cameras).This was discovered during a case with no patient harm.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3355-4030 serial/batch number 1319730 was received for evaluation.Functional testing could not be conducted because the device was damaged.Upon visual inspection, damage was observed in the lens, shaft, and housing.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• 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: 18888191
• Report Number: 1220246-2024-01431
• Device Sequence Number: 7550985
• Product Code: HRX
• UDI-Device Identifier: 00888867029842
• UDI-Public: 00888867029842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• 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): 08/29/2024

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: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• Device Catalogue Number: AR-3355-4030
• Device Lot Number: 10224124
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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