MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX FIBERTAK DISPOSABLES CURVED KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AR-3638DC
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Arthrex 1.8 knotless fiber tak soft anchor implanted in left shoulder.The anchor inserter was visually inspected upon withdrawal.It was noted that the two prongs at the tip of the inserter had broken off and remained imbedded in the bone.Another 1.8 knotless fiber tak soft anchor was inserted, and the same situation occurred.Both anchors had a lot# of 15104066 to complete surgery above lot # anchors removed and another lot # of arthrex anchors used without incident.Surgery was completed.

• Brand Name: ARTHREX FIBERTAK DISPOSABLES CURVED KIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 19309755
• Report Number: 19309755
• Device Sequence Number: 6911608
• Product Code: LXH
• UDI-Device Identifier: 00888867287433
• UDI-Public: (01)00888867287433
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2024
• Report Date (Section F): 01/17/2024

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: AR-3638DC
• Device Catalogue Number: AR-3638DC
• Device Lot Number: 15104066
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/17/2024