MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT II; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,CRKSCRW FT II
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales rep via email that a ar-1928sft-2-1, sutr anch, crkscrw ft ii eyelet broken whilst tying knots on 5.5mm metal corkscrew ar-1928sft-2.Knot tying and insertion was performed as per the technique guide.The surgeon has used this anchor many times.This was discovered during use and a case was involved.To complete the procedure, a new anchor was used.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional info: h6.The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to prying/leveraging the anchor during insertion.

• Brand Name: SUTR ANCH,CRKSCRW FT II
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15657683
• Report Number: 1220246-2022-05663
• Device Sequence Number: 17771931
• Product Code: MBI
• UDI-Device Identifier: 00888867023765
• UDI-Public: 00888867023765
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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 Model Number: SUTR ANCH,CRKSCRW FT II
• Device Catalogue Number: AR-1928SFT-2-1
• Device Lot Number: 13036380
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown