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

Model Number SUTR ANCH,CRKSCRW FT III

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2020

Event Type  Injury  

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 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
• Type of Device: 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: 10157841
• MDR Text Key: 195292627
• Report Number: 1220246-2020-01890
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867023727
• UDI-Public: 00888867023727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SUTR ANCH,CRKSCRW FT III
• Device Catalogue Number: AR-1928SF-3
• Device Lot Number: 10566196
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other