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

Model Number	SUTR ANCH,CRKSCRW
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by an arthrex employee via e-mail that an ar-1920snf suture anchor sutures failed/broke.This occurred during a knee arthroscopic procedure on (b)(6) 2021.The anchor was removed and the case was completed by using a new ar-1920snf.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the suture was broken.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: 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: 13471800
• Report Number: 1220246-2022-04420
• Device Sequence Number: 13881588
• Product Code: HWC
• UDI-Device Identifier: 00888867022843
• UDI-Public: 00888867022843
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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 Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1920SNF
• Device Lot Number: 14107967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown