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

Model Number	SUTR ANCH,CRKSCRW
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2020
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 dex procedure, the corkscrew suture anchor, ar-1915snf, remained in the patient's bone.The surgeon had to change surgical technique so another anchor was not necessary.No further details, additional information requested.Additional information provided 10/15/2020: no instrument was used to prep the patient's bone.The patient is said to have had good quality bone.The eyelet broke off and was retrieved.The anchor was correctly used but at some point a click was heard and the device came out just with sutures.The surgeon changed technique and completed the case with intraosseous tunnels and sutures.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10730525
• Report Number: 1220246-2020-02257
• Device Sequence Number: 11627355
• Product Code: HWC
• UDI-Device Identifier: 00888867022676
• UDI-Public: 00888867022676
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 05/31/2025
• Device Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1915SNF
• Device Lot Number: 11089129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/23/2020
• 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