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

Model Number	SUTR ANCH,CRKSCRW FT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
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 that during a shoulder cuff repair surgery the little pin in the center of the screen, holding the fiber wire, came off.Due to this failure the fiber wire pulled out.The surgeon was able to retrieve the piece out of the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 12-mar-2021: further information was provided that the pin in the center of the screw that holds the sutures of the 4.5mm corkscrew anchor came out.

• Brand Name: SUTR ANCH,CRKSCRW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11599212
• Report Number: 1220246-2021-02806
• Device Sequence Number: 3683915
• Product Code: HWC
• UDI-Device Identifier: 00888867023741
• UDI-Public: 00888867023741
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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 Expiration Date: 10/31/2024
• Device Model Number: SUTR ANCH,CRKSCRW FT
• Device Catalogue Number: AR-1928SF-45
• Device Lot Number: 10460671
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/31/2021
• Patient Sequence Number: 1