MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE; ARTHROSCOPE AND ACCESSORIES

Model Number	SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 7th june 2024 it was reported by a arthrex employee via email that an ar-3373-4002, sheath, hf, tap/fen, 2 stopcock for 4.0 mm scope suction port was broken.This was detected during use in a shoulder surgery on (b)(6) 2024 with no patient harm.The procedure was completed successfully as the device was changed to another one.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-3373-4002, serial/batch number 1743307, was received for investigation.The visual inspection revealed that the stopcocks had become detached at the weld.Signs of wear were observed at the shaft tip.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
• 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: 19654279
• Report Number: 1220246-2024-06544
• Device Sequence Number: 6549698
• Product Code: NBH
• UDI-Device Identifier: 00888867198579
• UDI-Public: 00888867198579
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 08/30/2024

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: SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
• Device Catalogue Number: AR-3373-4002
• Device Lot Number: 1743307
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown