MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT II; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, CORKSCREW FT II
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On the (b)(6) 2022, it was reported by the sales rep that the surgeon was doing his standard rotator cuff repair using a 5.5mm suture anchor, corkscrew ft ii.The surgeon had already inserted 2 of them successfully.However, when the third anchor was placed in the medial row, after he had passed the sutures & tied his knots, the suture eyelet inside the anchor that contains the sutures broke.The small white suture eyelet coming out of the anchor broken was visible.The surgeon mentioned this was the second time in a few weeks the same issue had occurred.He was unable to remove the anchor, the metal anchor remains insitu.Another corkscrew anchor was placed over the top of the existing anchor which was successful, and the repair completed in his standard technique.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT II
• Common Device Name: SCREW, FIXATION, BONE
• 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: 15758726
• Report Number: 1220246-2022-05726
• Device Sequence Number: 15009383
• Product Code: HWC
• UDI-Device Identifier: 00888867023710
• UDI-Public: 00888867023710
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

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: SUTURE ANCHOR, CORKSCREW FT II
• Device Catalogue Number: AR-1928SF-2-1
• Device Lot Number: 13036380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown