MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
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 eyelets of two devices from the article ar-1915snf (lot 11332534) tore off during insertion of the devices into the bone.No broken parts remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Two unpackaged ar-1915snf suture anchor assemblies (no batch indicators present) were received for investigation.Visual inspection identified that the corkscrew anchors had broken off at the interface points with the drive assemblies.The fragments generated during this event were not returned for analysis.It was identified that the method of bone preparation used, as well as the bone quality encountered during the procedure, were not provided.As such, the observed condition is most likely the result of improper bone preparation, off-axis insertion, and/or prying/leveraging the anchors during insertion.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11647669
• Report Number: 1220246-2021-02876
• Device Sequence Number: 3832885
• Product Code: HWC
• UDI-Device Identifier: 00888867022676
• UDI-Public: 00888867022676
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 06/30/2025
• Device Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1915SNF
• Device Lot Number: 11332534
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1