MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT III; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW FT III
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
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 a rotator cuff repair procedure, on (b)(6) 2020, the following incident occurred: post implantation of an ar-1928sf-3 (lot 10331327), triple loaded corkscrew, the surgeon passed all sutures through the rotator cuff.Surgeon tied the first set, which was fine.Surgeon then tied the second set of sutures and the #2 fiberwire broke at the knot stack.Surgeon went to transfer the third set of sutures through the passport and upon retrieving and pulling adequate tension, the suture snapped in the joint.The surgeon used the corkscrew as a traction device, passed a fibertape through the remaining piece of rotator cuff that need to be secured and implanted speed fix technique with a swivelock.The technique was changed from a suture bridge to a knotless technique due to the issue that occurred.The rep reported that the surgeon felt that the implant acted as a traction stitch and used it to aid in his knotless technique.All fiberwire that broke was retrieved from the patient.The actual implant itself was fine and left in the patient.It had been implanted with the correct technique.The sliding suture was the issue.The facility discarded the sutures that were removed.The facility will be returning two unopened ar-1928sf-3 with the same lot number for use in evaluation.

• Brand Name: SUTR ANCH,CRKSCRW FT III
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10108925
• Report Number: 1220246-2020-01868
• Device Sequence Number: 3406666
• Product Code: HWC
• UDI-Device Identifier: 00888867023727
• UDI-Public: 00888867023727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: SUTR ANCH,CRKSCRW FT III
• Device Catalogue Number: AR-1928SF-3
• Device Lot Number: 10331237
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/02/2020
• 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