MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN; POWERED SURG ORTHOPEDIC INSTR

Model Number	DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
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.Complaint confirmed.One unpackaged ar-1938dss was received for investigation.Visual inspection identified that the drill bit had cold-welded to the metal sleeve of the drill guide and was unable to be removed for dimensional analysis.The plastic of the guide was noticeably bent/damaged.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.
Event or Problem Description
On 11/4/2021, it was reported by a sales representative via sems that an ar-1938dss suturetak kit's drill bit got stuck in the guide.This was discovered during a procedure.

• Brand Name: DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
• 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: 19393375
• Report Number: 1220246-2024-03875
• Device Sequence Number: 15391888
• Product Code: HWE
• UDI-Device Identifier: 00888867287389
• UDI-Public: 00888867287389
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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 Expiration Date: 02/28/2026
• Device Model Number: DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
• Device Catalogue Number: AR-1938DSS
• Device Lot Number: 12824023
• 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: 11/04/2021
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown