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	05/26/2020
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
During a rotator cuff repair procedure it was discovered the suture anchor only had two sutures instead of three.A second hole was drilled and another corkscrew was used to secure the area.The doctor decided to use a second implant because there was only two sutures on the first.He was very satisfied all was secure after the second was implanted.The case was continued and completed with no further issues.The patient is fine to date.

• 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: 10157841
• Report Number: 1220246-2020-01890
• Device Sequence Number: 17091739
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

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: 12/31/2024
• Device Model Number: SUTR ANCH,CRKSCRW FT III
• Device Catalogue Number: AR-1928SF-3
• Device Lot Number: 10566196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/16/2020
• 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