MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT,3.5X 10MM; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW FT,3.5X 10MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
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 during an knee arthroscopic procedure, the surgeon used the ar-1595ft anchor, which first impacted the indicator pin and then the surgeon proceeded to place the anchor ar-1915ft, in which the thread passes but a portion of the anchor handle split causing the device to disassemble.All fragments were removed and the case was completed by using another ar-1915ft.No patient harm.
Additional Manufacturer Narrative
Complaint confirmed.Two ar-1915ft drive assemblies (no batch/sn numbers present) were received for investigation.Visual inspection identified that the distal tips of both drive shafts had broken at the interface point with the anchor.It was determined that one driver had approximately 1.4197mm of its distal tip remaining, and the second driver had approximately 0.7795mm of its distal tip remaining.Material analysis identified that both drive shafts met all as-received specifications.The observed condition is most likely the result of user applied mechanical forces during use, such as through prying/leveraging the drivers during anchor insertion.Additionally, the method used to prepare the bone, as well as the bone quality encountered, were not recorded.As such, another potential most probable cause can be linked to improper bone preparation before use.

• Brand Name: SUTR ANCH,CRKSCRW FT,3.5X 10MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11301180
• Report Number: 1220246-2021-02555
• Device Sequence Number: 3737662
• Product Code: HWC
• UDI-Device Identifier: 00888867022607
• UDI-Public: 00888867022607
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061863
• 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): 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: SUTR ANCH,CRKSCRW FT,3.5X 10MM
• Device Catalogue Number: AR-1915FT
• Device Lot Number: 10846521
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/12/2021
• 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