MAUDE Adverse Event Report: ARTHREX, INC. FIBER TAK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	AR-3602
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, patient had shoulder surgery for a shoulder slap tear.On (b)(6) complaint of pain in an anterior aspect, on x-ray there was an incidental finding of a broken inserter tip still in the shoulder not near area of pain.On (b)(6) 2022 removal of 1.5 mm broken piece of instrumentation was removed.The piece was not noted broken during original surgery on (b)(6) 2022.Fda safety report id# (b)(4).

• Brand Name: FIBER TAK SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; naples FL 34108
• MDR Report Key: 14632607
• Report Number: MW5110183
• Device Sequence Number: 5901611
• Product Code: MBI
• UDI-Device Identifier: 00888867206946
• UDI-Public: (01)00888867206946
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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
• Device Model Number: AR-3602
• Device Catalogue Number: AR-3602
• Device Lot Number: 14917758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 DA
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White