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	12/29/2020
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 arthroscopic and ligament repair, when the surgeon placed the anchor, ar-1915ft, on the last turn, a portion of the anchor handle split.In addition to the split handle the suture broke when knotting.All fragments were removed and the case was completed by using another ar-1915ft.No patient harm.
Additional Manufacturer Narrative
It was reported that the shafts of the devices had fractured off.The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that both of the shafts had fractured distal to the devices.The suture constructs were returned disassembled with no apparent malfunction.Additionally, the anchors were not returned.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is prying / leveraging the devices while applying excessive mechanical forces upon insertion.

• 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: 11301163
• Report Number: 1220246-2021-02554
• Device Sequence Number: 19053378
• 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): 09/03/2021

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: 09/03/2021
• 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