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	02/24/2021
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 tip of the device broke during the surgery inside the patient.The broken piece was retrieved from the patient.There was no harm or adverse event for patient, operator or third party reported.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.Update 01-mar-2021: further information was received and the affected part number in this case is ar-1915sf-1.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1915sf-1 drive assembly (no batch indicator present) was received for investigation.Visual inspection identified that the corkscrew anchor had broken off the distal tip of the drive shaft, with remnants visible within the cannulation of the driver.The fragmented anchor detailed in the event description was not returned for analysis.Although the suture construct was returned with the driver, there was no fraying or breakage present across the suture.Material analysis identified that the driver shaft met all as-received specifications.It was noted that the method of bone preparation, as well as the bone quality encountered, were not recorded.As such, the observed condition is most likely the result of improper bone preparation, off-axis insertion, and/or prying/leveraging the device 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: 11473397
• Report Number: 1220246-2021-02701
• Device Sequence Number: 2965741
• Product Code: HWC
• UDI-Device Identifier: 00888867023208
• UDI-Public: 00888867023208
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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 Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1925SF-1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1