MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MICRO CORKSCREW FT; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the anchor was detached from the tip of the micro corkscrew suture anchor, ar-1318ft-40.There surgeon was able to reattach it; however, the suture broke during insertion.A new micro corkscrew suture anchor was opened to complete the case with no adverse effect to the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1318ft-40 driver assembly (no batch indicator present) was received for investigation.Visual inspection identified no abnormalities to the driver itself.Two spd-40-01n white fiberwire fragments were returned within the handle of the drive assembly.Fraying was observed at the ends of both braids.One fragment measured in at approximately 8.31", whereas the other measured approximately 8.40".This was determined using calibrated ruler.The root cause of the breakage remains undetermined, although the most probable cause is user applied mechanical forces during use.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11599106
• Report Number: 1220246-2021-02805
• Device Sequence Number: 3683914
• Product Code: HWC
• UDI-Device Identifier: 00888867008526
• UDI-Public: 00888867008526
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 02/28/2025
• Device Model Number: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT-40
• Device Lot Number: 10679277
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1