MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCHBIO-COMP S-TAK KNOTLESS; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCHBIO-COMP S-TAK KNOTLESS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
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 during a labral repair procedure the repair suture on a quantity two ar-1938bc anchors snapped as the surgeon was shuttling the repair stitch through the anchor body.There were multiple other ar-1938's used, but only the ones from this lot number broke in this manner.Sockets were drilled using the ar-1938d in the glenoid.Once the anchors broke, the surgeon drilled them out and collected the debris using a shaver.No piece from the unsuccessful anchors were left in the patient.

• Brand Name: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11730918
• Report Number: 1220246-2021-02964
• Device Sequence Number: 3721412
• Product Code: MAI
• UDI-Device Identifier: 00888867097186
• UDI-Public: 00888867097186
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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 ANCHBIO-COMP S-TAK KNOTLESS
• Device Catalogue Number: AR-1938BC
• Device Lot Number: 11515574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1